[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:large-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,51,71,117,143,178,209,226,262,283,315,333,357,401,422,448,465,481,505,523,553,583,623,644,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100629759","phase-1-radiation-oral-vancomycin-and-car-t-for-b-cell-lymphomas-100629759",false,"NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures","ALL","18 Years",{"count":20,"type":21},14,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[27,28,29,30,31],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[33,34,35,36,37],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2026-05-29",{"date":46,"type":21},"2029-01-01",{"name":48,"class":49},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":50},"100617237","phase-2-phase-2-trial-of-lisocabtagene-maraleucel-for-minimal-residual-disease-in-patients-with-large-b-cell-lymphoma-100617237","NCT07316010","Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma","Inclusion Criteria:\n\nPatients must meet the following criteria for study entry:\n\n2\\. Age ≥18 years 3. Histologically diagnosed 4. Diffuse large B-cell lymphoma, not otherwise specified (NOS) or 5. High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) 6. International Prognostic Index score ≥ 3 or 1-2 with LDH \\> 1.3 x ULN and\u002For bulky disease (single lesion of ≥ 7cm) 7. Received first line standard of care anthracycline-based chemoimmunotherapy for 6 cycles (with or without 2 more cycles of rituximab) for previously untreated disease\n\n* R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)\n* DA-EPOCH-R\n* Polatuzumab-R-CHP 8. Achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment\n* Or PR only if suitable for observation, defined as either negative biopsy or deemed too small or not amenable to biopsy 9. Had a response assessment within 8 weeks following completion of first line standard of care treatment 10. Detectable MRD after first line treatment (regardless of the ctDNA level) by Foresight CLARITY™12 11. Performance status ≤2 on the ECOG scale (section 6.2.5) 12. Adequate organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL\\*\n\n  \\*Growth factor permitted during screening\n* Platelet count ≥75 × 109 \u002FL\n* Hemoglobin ≥ 8 g\u002FdL\n* Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's syndrome\n* AST and ALT ≤ 3x upper limit of normal (ULN)\n* Alkaline phosphatase \\\u003C 2.5 ULN\n* Creatinine clearance \\>40 ml\u002Fmin calculated by modified Cockcroft-Gault formula or estimated GFR (eGFR) \\> 40 ml\u002Fmin\u002F1.73m2\n* Cardiac ejection fraction ≥ 40%, no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings 13. All subjects must\n* Agree to refrain from donating blood while on study treatment, and for at least 12 months following the last dose of study treatment.\n\n  14\\. The effects of liso-cel on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n* Postmenopausal (non-chemically induced menopause in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  15\\. Females of childbearing potential (FCBP) must:\n* Have 2 negative pregnancy tests as verified by the Investigator (one negative serum beta-human chorionic gonadotropin \\[ß-hCG\\] pregnancy test result at screening, and within 7 days prior to the first dose of LD chemotherapy). This applies even if the subject practices true abstinence2 from heterosexual contact.\n* Either commit to true abstinence from heterosexual contact (which must be reviewed monthly and source documented) or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the LD chemotherapy.\n* Agree to abstain from breastfeeding during study participation and for at least 12 months following LD chemotherapy.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  16\\. Male subjects must:\n* Male Practice true abstinence (which must be reviewed monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after LD chemotherapy even if he has undergone a successful vasectomy.\n\n  17\\. Willing and able to comply with the protocol treatment and procedures. 18. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nSubjects will be ineligible for this study if they meet any of following criteria:\n\n1. Having radiologically confirmed relapsed\u002Frefractory disease.\n2. Have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n3. Known central nervous system lymphoma or leptomeningeal disease.\n\n   • Suspicious case at end of treatment from first line treatment should be evaluated with brain MRI with or without lumber puncture.\n4. Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 2 years and felt to be at low risk for recurrence by the treating physician, except:\n\n   * Adequately treated localized non-melanoma skin cancer without evidence of disease.\n   * Adequately treated localized prostate cancer without evidence of disease.\n   * Adequately treated localized breast cancer without evidence of disease.\n   * Adequately treated cervical carcinoma in situ without evidence of disease.\n5. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.\n6. Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2.\n7. Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. The treatment and monitoring of hepatitis B will follow the institutional standard of practice. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n8. History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n9. History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.\n10. Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.\n11. History or presence of clinically significant central nervous system (CNS) pathology such as epilepsy (a seizure disorder), a seizure within the past 2 years prior to signing the ICF, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, Grade 3 or higher tremor, cerebellar disease, organic brain syndrome, or psychosis.\n12. Lactating or pregnant subjects. Pregnant women are excluded from this study for unknown potential for teratogenic or abortifacient effects by liso-cel. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with liso-cel, breastfeeding should be discontinued if the mother is treated with liso-cel. These potential risks may also apply to other agents used in this study.\n13. Had blood transfusion within 14 days prior to first dose of LDC.\n14. Administration of any investigational agent within 28 days of first dose of study drug.\n15. Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.\n16. Administration of a live, attenuated vaccine within 4 weeks before lymphodepleting treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.\n17. Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \\\u003C 10 mg\u002Fday prednisone. For corticosteroids, prednisolone \\>20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma-related symptoms, including during screening, and for prophylaxis or AE management during the trial.\n18. Patients who have concern for the accurate assessment of neuro toxicity.\n19. Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.",{"count":5,"type":21},[59],"PHASE2","The goal of the main clinical research study is to learn if treatment with a chimeric antigen receptor (CAR) T-cell therapy called lisocabtagene maraleucel (liso-cel) can help to prevent recurrence of large B-cell cell lymphoma in patients who have achieved complete response (CR) after standard first-line therapy but have tested positive for lymphoma DNA. CAR T therapy is a type of treatment that uses your own immune cells to fight your cancer. The safety of this treatment will also be studied.",[62],"Large B-cell Lymphoma",{"date":64,"type":42},"2026-06-30",{"date":66,"type":42},"2026-03-17",{"date":68,"type":21},"2031-03-21",{"name":70,"class":49},"M.D. Anderson Cancer Center",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100554529","phase-2-consolidation-of-first-line-mrd-remission-with-cema-cel-in-patients-with-lbcl-100554529","NCT06500273","Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL","A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma","ALPHA3","Key Inclusion Criteria:\n\n1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.\n2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.\n3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET\u002FCT evaluation\n4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.\n5. Adult participants ≥18 years of age.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.\n\nKey Exclusion Criteria:\n\n1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell\u002Fhistiocyte rich LBCL.\n2. Prior treatment with anti-CD19 targeted therapies.\n3. Anti-cancer treatment, including radiation, after end of treatment PET\u002FCT and\u002For MRD testing is performed.\n4. Active and clinically significant autoimmune disease.\n5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment.\n6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.",{"count":80,"type":21},250,[59],"This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.\n\nIn this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.\n\nPrior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.",[62],[85,36,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Diffuse large B-cell lymphoma","Primary mediastinal B-cell lymphoma","LBCL","High grade B-cell lymphoma","HGBCL","Double-hit lymphoma","High-risk lymphoma","Minimal Residual Disease","MRD","CAR T","Allogeneic CAR T","CD19","cema-cel","cemacabtagene ansegedleucel","PMBCL","Consolidation","First-line","Front-line","Frontline","PhasED-Seq™","CLARITY™","AlloCAR T™","2026-06-26",{"date":39,"type":42},{"date":110,"type":42},"2024-06-18",{"date":112,"type":21},"2032-12",{"name":114,"class":115},"Allogene Therapeutics","INDUSTRY",77,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":50},"100643153","phase-1-pola-r-chp-plus-sonrotoclax-in-untreated-bcl2-highdouble-hit-lbcl-100643153","NCT07638787","Pola-R-CHP Plus Sonrotoclax in Untreated BCL2-High\u002FDouble-Hit LBCL","A Single-Arm, Prospective Study of Pola-R-CHP Plus Sonrotoclax in Patients With Previously Untreated Large B-Cell Lymphoma (LBCL) With High BCL2 Expression \u002F Double-Hit Lymphoma","Inclusion Criteria:\n\n* Patients with newly diagnosed large B-cell lymphoma confirmed by histopathology, CD20-positive, excluding central nervous system lymphoma;\n* Patients aged 18 to 75 years;\n* International Prognostic Index score of 2 to 5;\n* Patients with high BCL-2 expression or double-hit lymphoma characteristics;\n* No prior anti-tumor treatment of any type;\n* Estimated survival time ≥ 6 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n* Measurable lesions confirmed by radiological examination, defined as: at least one lymph node lesion with the longest diameter \\> 1.5 cm, or at least one extranodal lesion with the longest diameter \\> 1.0 cm, and at least two accurately measurable perpendicular diameters;\n* Patients or their legal representatives must provide written informed consent before conducting any study-specific examinations or procedures;\n* No prior treatment for lymphoma (except glucocorticoids).\n\nExclusion Criteria:\n\n* Prior solid organ transplantation or stem cell transplantation;\n* Complicated with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases, etc.;\n* Suspected active or latent tuberculosis (confirmed by a positive interferon-gamma release assay);\n* Any of the following abnormal laboratory test values (unless these abnormalities are all caused by the underlying lymphoma):\n* Neutrophils \\\u003C 1.0×10⁹\u002FL;\n* Platelets \\\u003C 75×10⁹\u002FL;\n* Serum AST and ALT ≥ 2.5× upper limit of normal (ULN);\n* Total bilirubin ≥ 1.5×ULN;\n* Serum creatinine clearance \\\u003C 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Uncontrolled or significant cardiovascular diseases, including but not limited to:\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Primary cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, etc.;\n* Clinically significant QTc prolongation, with QTc interval \\> 470 ms (females) or 480 ms (males), second-degree type II atrioventricular block, or third-degree atrioventricular block;\n* Current or past history of central nervous system (CNS) diseases, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative diseases. However, participants with a history of stroke who have not had a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits as judged by the investigator are allowed to participate in the study;\n* Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;\n* Patients infected with human immunodeficiency virus (HIV);\n* History of other malignant tumors that may affect protocol compliance or interpretation of results:\n* Participants with a history of cured basal or squamous cell carcinoma of the skin, melanoma, or carcinoma in situ of the cervix at any time before the study are eligible to participate;\n* Participants with a history of untreated low-grade early-stage prostate cancer (Gleason score ≤ 6, Stage 1 or 2) at any time before the study are eligible to participate;\n* Participants who received adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for ≥ 2 years before enrollment are eligible to participate;\n* Participants with any other malignant tumor cured by appropriate radical treatment and in remission without treatment for ≥ 2 years before enrollment are eligible to participate;\n* History of immune-related adverse events following prior immunotherapy drug-related treatment, as follows: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding onychomycosis) at study enrollment, or major infections within 4 weeks before the start of Cycle 1;\n* Active hepatitis B virus (HBV) infection (positive result by PCR). For patients with positive HBsAg test results, HBV DNA test is required; if HBV DNA \\\u003C 10³ IU\u002Fml, they can be enrolled. If HBsAg test result is negative but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required; if HBV DNA \\\u003C 10³ IU\u002Fml, they can be enrolled;\n* Positive hepatitis C test result (serological test for hepatitis C virus \\[HCV\\] antibody):\n* Eligibility to participate is only allowed if the PCR test result for HCV RNA is negative in patients with positive HCV antibody;\n* Participants with a history of progressive multifocal leukoencephalopathy (PML);\n* Currently pregnant or breastfeeding, or planning to become pregnant during the study or within 12 months after the last dose;\n* Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.","75 Years",{"count":126,"type":21},40,[24,59],"This is a Phase I\u002FII study. The Phase I part will evaluate the safety and tolerability of sonrotoclax in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), using a standard 3+3 dose-escalation design, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). The Phase II part will assess the efficacy of the combination regimen in patients with previously untreated LBCL with high BCL2 expression or MYC\u002FBCL2 rearrangements.",[62],[87,131,132,133],"BCL2","DHL","Sonrotoclax","NOT_YET_RECRUITING","2026-06-25",{"date":64,"type":42},{"date":138,"type":21},"2026-06-15",{"date":140,"type":21},"2029-04-30",{"name":142,"class":49},"Ruijin Hospital",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100502329","phase-3-acalabrutinib-in-combination-with-r-minichop-in-older-adults-with-untreated-diffuse-large-b-cell-lymphoma-100502329","NCT05820841","Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma","A Randomized, Open-label, Phase 3 Study of Acalabrutinib in Combination With Rituximab and Reduced Dose CHOP (R-miniCHOP) in OldEr Adults With Untreated Diffuse Large B-Cell Lymphoma","ARCHED","Inclusion Criteria:\n\nInformed consent\n\n1. Ability to understand the purpose and risks of the study and capable of giving signed informed consent which includes:\n\n   1. Compliance with the requirements and restrictions listed in the informed consent form (ICF).\n   2. Authorization to use protected health information\u002Fdata \\[in accordance with the General Data Protection Regulation (GDPR)\\].\n2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses\n3. Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.\n\n   Age\u002FSex\n4. Men and women \\>80 years of age or \\>60 up to 80 years of age and ineligible for full dose R-CHOP according to investigator assessment\\*.\n\n   We recommend classifying patients aged 61-80 as full-dose R-CHOP ineligible if they fulfill one of the following criteria: ADL \\\u003C5, IADL \\\u003C6, CIRS-G ≥1 score = 3, or \\> 8 score = 2.\n5. Male patients who are sexually active with women of childbearing potential (definitions see section 17.8) must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study (see section 17.8.1) as well as to the restrictions mentioned in section 9.13.\n6. Female patients of childbearing potential (definitions see 17.8) who are sexually active must agree to use highly effective forms of contraception while on the study as well as to the restrictions mentioned in section 9.13.\n\n   Disease characteristics\n7. Histologically proven, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO classification including:\n\n   1. diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)\n   2. primary cutaneous DLBCL leg type\n   3. intravascular large B-cell lymphoma\n   4. EBV+ DLBCL, NOS\n   5. HHV8+DLBCL, NOS\n   6. primary mediastinal (thymic) large B-cell lymphoma\n   7. B-cell lymphoma, with intermediate features between DLBCL and classical Hodgkin lymphoma\n   8. follicular lymphoma grade 3B\n   9. high-grade B-cell lymphoma, NOS\n   10. high-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n   11. T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   12. DLBCL associated with chronic inflammation\n   13. ALK+ large B-cell lymphoma\n   14. large B-cell lymphoma with IRF4 rearrangement Please note: patients in whom indolent lymphoma is diagnosed concurrently with the one of the above listed diagnoses can also be included.\n8. Disease Stage I with bulk ≥7.5cm, II, III or IV according to Ann Arbor Classification Type of patient and clinical characteristics\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. An ECOG Score of 3 is acceptable only if this is directly attributable to lymphoma.\n10. Meet the following laboratory parameters:\n\n    1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fµl or platelet count ≥ 100.000\u002Fµl unless directly attributable to lymphoma.\n    2. Serum AST and ALT ≤3 x upper limit of normal (ULN) unless directly attributable to lymphoma.\n    3. Total bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert's syndrome or lymphoma.\n    4. Estimated creatinine clearance of ≥30 mL\u002Fmin, calculated by Cockcroft-Gault (using actual body weight) (if male, \\[140-Age\\] x Mass \\[kg\\] \u002F \\[72 x creatinine mg\u002FdL\\]; multiply by 0.85 if female), or serum creatinine ≤2.5 x ULN.\n\nExclusion Criteria:\n\nMedical conditions\n\n1. Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol \\[e.g. a single score of 4 on one single category on the CIRS-G-Score (but not a cumulative score of 4)\\].\n2. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF \\\u003C 40%. Patients with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.\n3. Severe pulmonary dysfunction (CTCAE grade 3 or 4) unless associated with lymphoma.\n4. Severe psychiatric or neurologic disease that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.\n5. Persistent neuropathy CTCAE grade 3 or 4.\n6. Refractory nausea and vomiting, inability to swallow acalabrutinib, or malabsorption syndrome; chronic severe gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment.\n7. History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:\n\n   1. Curatively treated localised basal cell carcinoma or localised squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ \u002F low risk carcinoma of the prostate requiring only observation, as well as untreated low grade lymphoma except chronic lymphocytic leukemia.\n   2. Other cancers not specified above that have been curatively treated by surgery and\u002For radiation therapy from which patient is disease-free for ≥2 years (≥5 years for those treated with chemotherapy) without further treatment or which are not expected to limit survival to \\\u003C 2 years.\n8. Received a live virus vaccination within 28 days of randomization.\n9. Known history of infection with HIV.\n10. Any active significant infection (e.g., bacterial, viral or fungal) as assessed by the investigator.\n11. History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).\n12. Serologic status reflecting active hepatitis B or C infection.\n\n    1. Patients who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HBsAg-positive or hepatitis B PCR positive will be excluded.\n    2. Patients who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.\n13. History of stroke or intracranial hemorrhage within 6 months before randomization.\n14. History of clinically relevant bleeding diathesis (e.g., hemophilia, von Willebrand disease).\n15. Major surgical procedure within 30 days before randomization. Note: If a patient had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n16. Breastfeeding or pregnant women.\n17. Current life-threatening illness, medical condition, organ system dysfunction, social, geographical or economic condition which, in the Investigator's opinion, could compromise the patient's safety or put the study at risk.\n18. Diagnosis of primary central nervous system lymphoma or secondary central nervous system or meningeal involvement by lymphoma\n19. Diagnosis of Richter's Transformation\u002Ftransformed CLL Prior\u002FConcomitant therapy\n20. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists. Patients using therapeutic low molecule weight heparin, direct oral anticoagulants or low dose aspirin will be eligible. Switching from vitamin K antagonists to one of the allowed anticoagulants above prior to trial entry is permitted.\n21. Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited. See details in section 9.12.1.\n22. Prior exposure to a BTK inhibitor.\n23. Prior anthracycline use ≥300 mg\u002Fm2.\n24. Already initiated lymphoma therapy except for steroid (max. total dose of 1000mg), vincristine (max. 1 mg once) or rituximab (max. 375mg\u002Fm2) prephase.\n25. Concurrent participation in another therapeutic clinical trial.\n26. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrolment into this study.\n27. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.","61 Years",{"count":153,"type":21},330,[155],"PHASE3","The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib.\n\nParticipants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.",[62,158],"Diffuse Large B Cell Lymphoma",[160,161,162,163,164,165,166,167,168],"Diffuse large B cell lymphoma","Older adults","Geriatric","Large B cell lymphoma","Aggressive B cell lymphoma","Acalabrutinib","R-miniCHOP","R-mini-CHOP","BTK inhibitor","2026-06-24",{"date":39,"type":42},{"date":172,"type":42},"2023-06-07",{"date":174,"type":21},"2029-02",{"name":176,"class":49},"Universität des Saarlandes",17,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100609515","phase-3-azd0486-1l-therapy-for-elderly-or-unfit-participants-with-lbcl-100609515","NCT07215585","AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL","A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)","SOUNDTRACK-D2","Inclusion criteria:\n\n* Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;\n* Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;\n* FDG-avid and measurable disease as per Lugano and Ann Arbor staging;\n* Stage I bulky (7.5 cm and greater) to Stage IV;\n* ECOG performance status 0 to 2;\n* Adequate bone marrow, liver, renal and cardiac function.\n\nThe above is a summary, other inclusion criteria details may apply.\n\n* As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol\n* Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).\n* History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition\n* Known history of hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome (HLH\u002FMAS).\n* Active or uncontrolled infection\n* Major cardiac abnormalities\n* Prior anti-lymphoma therapy except for corticosteroids for symptom control\n* Requires chronic immunosuppressive therapy for active autoimmune\u002Finflammatory condition, with some exceptions\n\nThe above is a summary, other exclusion criteria details may apply.","65 Years","130 Years",{"count":189,"type":21},420,[155],"The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.",[62],[62,87,194,195,96,196,197,198],"AZD0486","CD3","TCE","B-cell malignancies","Soundtrack-D2","2026-06-17",{"date":201,"type":42},"2026-06-18",{"date":203,"type":42},"2025-11-11",{"date":205,"type":21},"2033-07-28",{"name":207,"class":115},"AstraZeneca",68,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":215,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":223,"locationsCount":225},"100498892","expanded-access-study-for-the-treatment-of-patients-with-commercially-out-of-specification-axicabtagene-ciloleucel-100498892","NCT05776160","Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel","Inclusion Criteria:\n\n* Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)\n* Deemed medically fit and stable to receive the product per the investigator's evaluation\n* Repeat leukapheresis is not feasible per the investigator's assessment\n* Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release\n* In the investigator's opinion, there is no satisfactory alternative therapy available to the individual\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel\n* Uncontrolled active infection or inflammation per physician assessment\n* Primary central nervous system lymphoma","EXPANDED_ACCESS","The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.",[62,218],"Follicular Lymphoma","AVAILABLE","2026-06-11",{"date":222,"type":42},"2026-06-12",{"name":224,"class":115},"Kite, A Gilead Company",128,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100559431","phase-1-a-study-of-azd0486-monotherapy-or-in-combination-with-other-anti-cancer-agents-for-mature-b-cell-malignancies-100559431","NCT06564038","A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies","A Phase I\u002FII Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies","Soundtrack-E","Inclusion Criteria:\n\nMaster Inclusion Criteria applicable to all substudies:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Contraception use during treatment and at least 90 days after final dose.\n* Confirmed CD19 expression if prior anti-CD19 therapy.\n\nSubstudy 1 Specific Inclusion Criteria:\n\n* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n* SLL: at least 1 measurable site per Lugano.\n* Absolute lymphocyte count (ALC) \\\u003C25000 cells\u002FmcL.\n* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL\u002FSLL.\n* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.\n\nSubstudy 2 Specific Inclusion Criteria:\n\n* MCL diagnosis per WHO.\n* Clinical Stage II, III, or IV by Ann Arbor Classification.\n* At least 1 measurable site per Lugano.\n* ALC \\\u003C 25000 cells\u002FmcL.\n* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.\n\nSubstudy 3 Specific Inclusion Criteria:\n\n* At least 1 measurable site as per Lugano.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Participant must be no older than 79 years of age at the time of signing ICF.\n* Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.\n* Cohort 3A:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. R\u002FR B-NHL after at least 1 prior lines of systemic therapy.\n  3. International Prognostic Index (IPI) 2-5.\n* Cohort 3B:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. IPI score of 2 to 5.\n\nExclusion Criteria:\n\nMaster Exclusion Criteria applicable to all substudies:\n\n* Central nervous system (CNS) lymphoma.\n* Surgery within 14 days of study drug.\n* Clinically significant cardiovascular (CV) disease.\n* Unresolved Grade \\>2 AEs from prior anticancer therapy (except alopecia or fatigue).\n* Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.\n* Radiation therapy within 28 days.\n* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.\n* Prior Grade \\> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.\n* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.\n* Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).\n\nSubstudy 1 Specific Exclusion Criteria:\n\n* CLL\u002FSLL transformation to more aggressive form of lymphoma.\n* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.\n\nSubstudy 3 Specific Exclusion Criteria:\n\n* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).\n* Cumulative dose of anthracycline \\>150 mg\u002Fm2.",{"count":235,"type":21},408,[24,59],"The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies",[239,240,241,62,242],"Chronic Lymphocytic Leukaemia","Small Lymphocytic Lymphoma","Mantle-cell Lymphoma","B-cell Non-Hodgkin Lymphoma",[244,245,246,165,247,248,249,250,251,252],"IgG4 fully human CD19xCD3 bispecific T-cell engager","B cell lymphoma","Subcutaneous","Prednisone","Rituximab","Cyclophosphamide","Vincristine","Doxorubicin","Surovatamig","2026-06-09",{"date":255,"type":42},"2026-06-10",{"date":257,"type":42},"2025-01-30",{"date":259,"type":21},"2029-06-11",{"name":207,"class":115},64,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":50},"100528977","phase-2-a-study-to-evaluate-zanubrutinib-and-tislelizumab-in-progressive-lymphoma-post-car-t-100528977","NCT06167785","A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T","A Prospective, Multicenter, Phase II Trial to Evaluate the Efficacy of Zanubrutinib and Tislelizumab as Well as Standard of Care for the Treatment of Patients With Progressive Lymphoma Post Anti-CD19 CAR-T Cell Therapy","ZeTA","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Able and willing to provide written informed consent and to comply with the study protocol\n3. Radiologically measurable disease (≥ 1 nodal lesion \\> 2.0 cm in the longest diameter, and\u002For extranodal lesion \\> 1.0cm in the longest diameter)\n4. Intervention arm: Radiological measurable disease per inclusion criterion #3 with more than one site of disease.\n5. Relapse or refractory Large B cell Lymphoma post-CD19 directed CAR-T cell therapy within 6 weeks prior to enrollment (histological confirmation highly recommended although not mandatory)\n6. Intervention arm: Hemoglobin ≥ 80 g\u002FL at screening\\*\n7. Intervention arm: Platelet count ≥ 75 x 109\u002FL at screening\\*\n8. Intervention arm: Neutrophil count ≥ 1.0 x 109\u002FL at screening\\*\n9. Intervention arm: ECOG performance status ≤ 2 at screening\n10. AST and ALT \\\u003C 2.5 x ULN at screening\n11. Serum total bilirubin \\\u003C 1.5 x ULN, except in patients with documented Gilberts syndrome at screening\n12. Creatinine clearance ≥ 30 mL\u002Fmin as estimated by Cockcroft-gault equation at screening \\* Counts can be supported with growth factors or transfusions as per standard transfusion protocols.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C 30 days at the time of enrollment\n2. Prior exposure to BTK or PD-1 inhibitor at any time prior to enrollment\n3. Prior anaphylactic reaction to monoclonal antibody therapy at any time prior to enrollment\n4. Intervention arm: On higher than physiologic doses (10mg daily) of prednisone daily at least 7 days prior to initiation of trial treatment. SOC arm: On prednisone for symptom management only.\n5. Uncontrolled autoimmune disease\n6. Known active CNS involvement disease\n7. History of prior allogeneic transplant or organ transplant\n8. Active bleeding or history of bleeding diathesis including, but not limited to,\n\n   * History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n   * History of stroke or intracranial hemorrhage within 180 days before first dose of study drug\n9. Difficulty with or unable to swallow oral medication, or known conditions that would significantly affect gastrointestinal function that would limit absorption of oral medication\n10. History of chronic or active, uncontrolled bacterial, viral or fungal infection; human T-cell lymphotropic virus type 1 seropositive status.\n11. Serologic status reflecting active viral hepatitis B or C infection as follows:\n\n    1. presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\\\u003C 20IU), and if they are willing to be on appropriate prophylaxis and undergo monitoring for HBV reactivation if clinically indicated.\n    2. Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable.\n12. Individuals with known active HIV infection are eligible if CD4 and viral titres are controlled\n13. Any serious intercurrent illness, life threatening condition, organ system dysfunction including:\n\n    * (1) Clinically significant cardiovascular including:\n\n      1. prolonged QTc \\> 480ms,\n      2. history of Mobitz II second degree or third degree heart block without a permanent pacemaker in situ,\n      3. uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure reading on 2 separate occasions showing systolic BP \\> 170 mmHg and\u002For diastolic BP \\> 105mmHg at screening,\n      4. uncontrolled or history of symptomatic arrhythmias (ie. sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes),\n      5. congestive heart failure or NYHA class ≥ 3,\n      6. myocardial infarction within 6 months prior to enrollment;\n    * (2) History of significant cerebrovascular events including stroke or intracranial hemorrhage within 6 months prior to enrollment\n14. History of other active malignancies within 2 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of cervix; localized basal cell or squamous cell carcinoma of skin; or previous malignancy confined and treated locally (surgery or other modality) with curative intent.\n15. Female patients of childbearing potential must practice highly effective methods (Section 6.7.1.1) of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 120 days after the last dose of zanubrutinib or tislelizumab\n16. Male patients are eligible if vasectomized or if they agree to the use of barrier contraception with highly effective methods during the study treatment period and for ≥ 120 days after the last dose of zanubrutinib or tislelizumab.\n17. Major surgery within 4 weeks of the first dose of study drug\n18. Vaccination with a live vaccine within 28 days prior to the first dose of study drug\n19. Patient requires treatment with warfarin or other vitamin K antagonists\n20. Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, congestive obstructive pulmonary disease).\n21. History of interstitial lung disease or non-infectious pneumonitis or pulmonary fibrosis, except for those induced by radiation therapy.\n22. Active and symptomatic fungal, bacterial, and\u002For viral infection; human T-cell lymphotropic virus type 1 seropositive status.\n23. Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any study endpoint.\n24. Active autoimmune diseases or history of severe autoimmune diseases; these include but are not limited to a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's disease, ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, or clinically manifest antiphospholipid syndrome. Note: Subjects are permitted to enroll if they have vitiligo, eczema, type I diabetes mellitus, or endocrine deficiencies, including thyroiditis managed with replacement hormones including physiologic doses of corticosteroids. Subjects with Sjögren's syndrome and psoriasis controlled with topical medication and subjects with positive serology, such as antinuclear antibodies or antithyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.\n25. A condition requiring systemic treatment with either corticosteroids (\\> 20 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration, except for PCNSL and SCNSL. Note: adrenal replacement doses ≤ 20 mg daily prednisone or equivalents are permitted in the absence of active autoimmune disease; subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).\n26. Major surgery in the past 4 weeks prior to the first day of screening.\n27. Patients with contraindications for zanubrutinib and Tislelizumab\n28. Pregnant or lactating women.\n29. Hypersensitivity to zanubrutinib and Tislelizumab or any of the other ingredients of the applicable study drugs\n30. Patients with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not constituting a likely safety risk\n31. With uncontrolled diabetes or \\> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before randomization.",{"count":271,"type":21},76,[59],"This is a phase ll study of participants with large B Cell lymphoma previously treated with anti-CD19 Chimeric antigen receptor (CAR-T) therapy. The purpose of the study is to to evaluate the efficacy of zanubrutinib and tislelizumab in patients with progressive lymphoma post anti-CD 19 CAR-T failure.",[62],"2026-06-05",{"date":253,"type":42},{"date":278,"type":42},"2025-06-04",{"date":280,"type":21},"2029-12",{"name":282,"class":49},"University Health Network, Toronto",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100607438","phase-3-a-study-to-investigate-ronde-cel-versus-investigators-choice-cd19-car-t-cell-therapy-100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":292,"type":21},400,[155],"This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[62,296,297,298,299,300,29,30,31],"Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed",[302,299,303,96,304,62],"Lymphoma","CAR T-Cell Therapy","CD19\u002FCD20","2026-06-04",{"date":307,"type":42},"2026-06-08",{"date":309,"type":42},"2026-01-12",{"date":311,"type":21},"2032-01",{"name":313,"class":115},"Lyell Immunopharma, Inc.",38,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":50},"100605588","phase-2-phase-2-trial-of-cd70car-nk-cells-for-patients-with-primary-refractory-or-early-relapsed-diffuse-large-b-cell-lymphoma-and-hodgkin-lymphoma-100605588","NCT07164469","Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma","Inclusion Criteria:\n\n1. 18-75 years of age.\n2. Diagnosis of cHL or DLBCL that is either:\n\n   * Primary refractory, defined as not having achieved a CR with frontline therapy or having relapsed within 3 months.\n   * Early relapsed (≤ 12 months) after achieving a CR to frontline therapy.\n3. Tumor biopsy positive for CD70 \\>\u002F= 10% by immunohistochemistry or flow cytometry.\n4. Measurable disease, defined by one or more histologically confirmed hypermetabolic lesion on PET\u002FCT scan.\n5. ECOG PS ≤ 2 (Karnofsky ≥60%).\n6. Adequate blood counts (WBC \\> 2K, HGB \\> 8 g\u002FdL, platelets \\> 50K).\n7. Creatinine clearance ≥ 30 ml\u002Fmin.\n8. ALT and\u002For AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN.\n9. FEV1, FVC and DLCOc ≥ 50%.\n10. LVEF ≥40%, without active arrythmias.\n11. If female of child-bearing potential, she must not be pregnant or breastfeeding and is required to have a negative urine or serum pregnancy test prior to enrollment.\n12. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n15. Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n16. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n\n    To be eligible for this trial, patients should be class 2B or better.\n17. The effects of CAR-NK cells on the developing human fetus are unknown. For this reason and because fludarabine and cyclophosphamide, as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).\n\n    * This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). History of bilateral tubal ligation or another surgical sterilization procedure.\n    * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n    * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CAR NK cell administration.\n18. Ability to understand and the willingness to sign a written informed consent document.\n19. Agree to sign consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies.\n\nExclusion Criteria:\n\n1. Lymphoma in CR with no measurable sites of disease.\n2. Major surgery \\\u003C4 weeks prior to first dose of study drug.\n3. Any other severe or uncontrolled disease or condition which might increase the risk associated with study participation.\n4. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n5. Grade \\>\u002F= 3 non-hematologic toxicity from prior therapy that has not improved to grade \\\u003C\u002F= 2.\n6. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA\n\n   \\>\u002F=10,000 copies\u002FmL, or \\>\u002F=2,000 IU\u002FmL), or hepatitis C (detectable viral load by HCV RNA PCR).\n7. Active infection requiring parenteral antibiotics.\n8. HIV infection.\n9. Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.\n10. Active central nervous system (CNS) involvement (untreatedparenchymal brain metastasis or positive cytology of cerebrospinal fluid).\n11. Life expectancy \\\u003C\u002F= 6 months.\n12. Active and uncontrolled neurological disorder.\n13. Patients receiving systemic steroid therapy at time of enrollment (physiological replacement doses are allowed) or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n14. Patients receiving immunosuppressive therapy.",{"count":322,"type":21},100,[59],"This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.",[62,326],"Hodgkin Lymphoma",{"date":307,"type":42},{"date":329,"type":21},"2026-06-28",{"date":331,"type":21},"2033-09-30",{"name":70,"class":49},{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":340,"studyType":341,"phases":4,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100592495","glofitamab-in-real-life-100592495","NCT06994169","Glofitamab in Real Life","Inclusion Criteria:\n\n* patient enrolled in the French Glofitamab EAP for R\u002FR DLBCL before 2024 November 1st, 2024\n* patient who received at least Obinutuzumab pretreatment and one infusion of Glofitamab\n* adult patient\n* patient who is informed of the study and who did not oppose to their data collection\n\nExclusion Criteria:\n\n* none",{"count":80,"type":21},"6 Months","OBSERVATIONAL","To date, more than 300 patients have been treated with Glofitamab in the Expanded Access Programme (EAP) in France. In this study, it is proposed to perform a retrospective analysis of some of these patients. The aim is to describe the efficacy and safety of Glofitamab in the largest reported real-world cohort, with an expected median follow-up of more than 9 months. Particular focus will be given to the relapsed or refractory chimeric antigen receptors-T (CAR-T) population to confirm the response rates (CRR: 35-39%) of Glofitamab in this population and to assess the optimal timing of therapy initiation \\[8, 15\\].",[62],[345,346],"CAR-T","Glofitamab","2026-06-02",{"date":349,"type":42},"2026-06-03",{"date":351,"type":42},"2025-12-01",{"date":353,"type":21},"2026-12-30",{"name":355,"class":49},"The Lymphoma Academic Research Organisation",30,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100502767","phase-1-study-of-rondecabtagene-autoleucel-in-aggressive-large-b-cell-lymphoma-100502767","NCT05826535","Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma","A Phase 1\u002F2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19\u002FCD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Willing and able to provide written informed consent\n3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)\n4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3\n5. Relapsed or refractory disease.\n6. At least 1 measurable lesion (per Lugano classification)\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)\n8. Absolute neutrophil count (ANC) ≥ 1000\u002FµL\n9. Platelet count ≥ 50,000\u002FµL\n10. Absolute lymphocyte count (ALC) ≥ 200\u002FµL\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years\n2. Active central nervous system involvement\n3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma\n4. Ongoing or impending oncologic emergency\n5. Recent systemic anti-cancer therapy or radiation\n6. Ongoing non-hematologic toxicities due to prior therapy\n7. History of allogeneic stem cell or solid organ transplantation\n8. Autologous stem cell transplantation within 6 weeks\n9. History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).\n10. Primary immunodeficiency\n11. History of autoimmune disease resulting in end organ injury or requiring recent therapy\n\nOther protocol-defined criteria apply.",{"count":365,"type":21},270,[24,59],"This is a Phase 1\u002F2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.",[297,298,299,62],[370,299,371,96,372,34,373,36,374,375,86,99,376,377,378,379,380,381,302,382,249,383,384,385,386,387,388,389,390,391],"CAR T-cell","CD19\u002F20","CD20","Diffuse Large B-cell lymphoma","Transformed follicular lymphoma","TFL","Follicular lymphoma Grade 3B","Large cell follicular lymphoma","Aggressive B-cell NHL","Refractory Aggressive B-Cell Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","Lymphoma, Large B-Cell, Diffuse","Fludarabine","Lymphoma, Follicular","Lymphoma, B-cell","Immunosuppressive Agents","Immunologic Factors","Disease Attributes","Immune System Diseases","Recurrence","PiNACLE","2026-05-26",{"date":394,"type":42},"2026-05-28",{"date":396,"type":42},"2023-05-09",{"date":398,"type":21},"2031-06-30",{"name":313,"class":115},34,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100430794","phase-2-car-t-followed-by-bispecific-antibodies-100430794","NCT04889716","CAR-T Followed by Bispecific Antibodies","Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* History of relapsed or refractory large B-cell lymphoma (including transformed follicular lymphoma, and follicular lymphoma Grade 3B) who have relapsed after or failed to respond to at least one prior standard systemic treatment regimen that contains an anthracycline and at least one containing an anti-CD20-directed therapy and for whom there is no available therapy expected to improve survival (e.g., standard chemotherapy, autologous or allogeneic stem cell transplant).\n* PET\u002FCT scan (preferred), diagnostic CT scan, or MRI prior to CAR-T cell therapy, with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \\[CT\\] scan with FDG-uptake ≥ liver); this imaging must have been obtained within 56 days of receiving CAR T cell therapy.\n* PET\u002FCT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \\[CT\\] scan with FDG-uptake ≥ liver); this imaging documenting measurable disease must be obtained at least day +28 after CAR T cell infusion and prior to cycle 1 day 1.\n* Be at least 30 days after CAR T-cell infusion at time of study enrollment.\n* Adequate laboratory studies,\n* Ability and willingness to take proper contraceptive precautions\n\nExclusion Criteria:\n\n* Had \\> Grade 3 cytokine release syndrome (CRS) by ASTCT criteria after CAR-T therapy or who have unresolved CRS after CAR-T therapy\n* Had ≥ grade 2 neurologic toxicity by ASTCT criteria after CAR-T therapy or who have active neurologic toxicity after CAR-T therapy\n* Inability to comply with protocol-mandated hospitalization and activities restrictions in the investigators' decision\n* Pregnant or lactating, or intending to become pregnant during the study or within 3 months after the last dose of bispecific antibody or 18 months of obinutuzumab, whichever comes later\n* Prior solid organ transplantation\n* Active systemic autoimmune disease or other disease requiring chronic immunosuppressive therapy\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)\n* Significant active pulmonary disease (e.g., bronchospasm and\u002For obstructive pulmonary disease) requiring oxygen or corticosteroid use.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to first mosunetuzumab or glofitamab administration. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients.\n* Recent major surgery within 4 weeks prior to first mosunetuzumab or glofitamab administration\n* Active or chronic infection(s) would have increased risks for toxicity if treated with bispecific antibody therapy, thus will be excluded.\n* Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study\n* Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment \\\u003C 20 mg\u002Fday prednisone or equivalent within 2 weeks prior to first dose of bispecific antibody\n* History of drug or alcohol abuse within 12 months prior to screening in the investigator's judgment\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and\u002For Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results",{"count":409,"type":21},23,[59],"The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion. Some patients who join the study will receive mosunetuzumab, other patients later in the study may receive a different experimental drug (glofitamab, in combination with obinutuzumab).",[62,413],"DLBCL - Diffuse Large B Cell Lymphoma","2026-05-21",{"date":392,"type":42},{"date":417,"type":42},"2021-11-05",{"date":419,"type":21},"2028-12-31",{"name":48,"class":49},2,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":50},"100638300","phase-1-golcadomide-with-pemetrexed-rituximab-and-dexamethasone-for-relapsed-and-refractory-cns-lymphomas-100638300","NCT07608731","Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas","Phase I Pilot Trial of Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas","Inclusion Criteria:\n\n* Participants or their legally acceptable representative must have signed and dated an IRB approved written ICF in accordance with regulatory, local, and institutional guidelines.\n* Participants ≥ 18 years of age.\n* Confirmed histopathological diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification. For participants with secondary CNS lymphoma, this can be confirmed by prior systemic biopsy. If a CNS lesion was not amenable for biopsy, imaging (e.g. MRI Brain ± MRI Full Spine) with CSF analysis for cytology may be used to confirm diagnosis, in lieu of a biopsy. Required. Acceptable histologies include:\n\n  * Large B-cell lymphoma NOS\n  * Diffuse large B-cell lymphoma (including GCB and ABC types)\n  * High-grade B-cell lymphoma with MYC and BCL2 rearrangements (double hit lymphomas)\n  * High-grade B-cell lymphoma NOS\n  * T-cell\u002Fhistiocyte\u002Frich large B-cell lymphoma (THRLBCL)\n  * EBV + DLBCL\n  * PMBCL\n  * Follicular Large B-Cell (previously referred to as Follicular Lymphoma, Grade 3B)\n* Participants must have active CNS lymphoma for which this trial is planned. Confirmation of the histology in relapsed setting is not required but participants must have measurable disease per the International PCSNL Collaboration Group Criteria (Section 11.1), as evidenced by at least one of the following:\n\n  * CNS disease on MRI (brain or spine including parenchymal and leptomeningeal)\n  * Detectable in the CSF\n  * Detectable on ophthalmologic exam\n* Participants must have received ≥ 1 prior systemic therapy for treatment of their CNS lymphoma. Participants who had systemic lymphoma and then relapsed with secondary CNS lymphoma must have received at least one prior line of therapy to specifically treat the CNS lymphoma.\n* Participants must have received prior high dose methotrexate as a line of therapy OR have been ineligible for methotrexate therapy based on the investigator's discretion.\n\n  * Participants who have received methotrexate as their first line of therapy but are no longer eligible for ongoing methotrexate and have persistent disease are eligible\n* ECOG performance status ≤ 0-3. PS 3 is allowed if it is disease related and not due to comorbidities or frailty and PS 4 is allowed if it is from CNS causing motor weakness and not due to comorbidities or frailty. (see Appendix I)\n* Adequate bone marrow function, defined by the following laboratory parameters:\n\n  * Absolute neutrophil ≥ 1.5 x 109\u002FL\n* Platelet count ≥ 100 x 109\u002FL\n\n  * Hemoglobin ≥ 8 g\u002FdL\n* Adequate organ function, defined by the following laboratory parameters:\n\n  * Adequate hepatic function, with transaminases (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and gamma glutamyl transferase \\[GGT\\]) ≤ 2.5 times the upper limit of normal\n* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n* Calculated creatinine clearance \\> 45 mL\u002Fmin by the Cockcroft-Gault equation.\n* Treating investigator must specify at screening:\n\n  * If the intent of therapy is a bridge to cellular therapy or to complete all six cycles of therapy. If bridge to cellular therapy is planned, the type of cellular therapy should also be specified at this time.\n  * If the r\u002Fr CNS lymphoma is primary or secondary\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two methods of contraception simultaneously from signing the ICF, at least 28 days before starting golcadomide, throughout the study, for up to 28 days following the last dose of golcadomide, and for 12 months after the last dose of rituximab, whichever is longer.. Two methods of contraception must include one highly effective method and one additional effective (barrier method).\n\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and\u002For uterus).\n\n    * Examples of contraceptive methods include highly effective methods such as oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; vasectomized partner and barrier methods with spermicide.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Must agree to pregnancy testing per protocol. This applies even if the participant practices true abstinence from heterosexual contact.\n    * Agree to abstain from breastfeeding or providing breast milk while on golcadomide and 28 days after discontinuation of golcadomide and according to the approved\n  * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 28 days after the last dose of study intervention or 90 days for rituximab, whichever is longer. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 28 days after the last dose of study intervention or 90 days for rituximab, whichever is longer.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Prior treatment toxicities not resolved to grade \\\u003C 2 according to NCI CTCAE 6.0 (with the exception of alopecia or grade 2 sensory peripheral neuropathy).\n* Participants receiving any other investigational agents.\n* History of anaphylactic reactions or severe allergic reactions prohibiting further administration attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in this study.\n* Autologous stem cell transplant within 30 days of start of study drug (C1D1).\n* CAR T-cell therapy within 90 days of start of study drug (C1D1).\n* Previous allogeneic stem cell transplant\n* Women who are pregnant or breastfeeding.\n* Clinically significant autoimmune disease.\n* Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus.\n* Malabsorption syndrome or other conditions that precludes enteral route of administration.\n* Chemotherapy or radiation within 2 weeks of the first scheduled study treatment\n* Participant is currently receiving warfarin. Particpants may begin screening if the plan is to change to an alternative anticoagulant such as a DOAC prior to enrollment.\n* Participant has current treatment with strong cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) modulators. The washout period for strong CYP3A4\u002F5 modulators is 7 days or 5 half-lives (whichever is longer) before initiation of golcadomide.\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n  * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.\n  * Other uncontrolled conditions including uncontrolled cardiovascular disease or arrhythmia, decompensated diabetes or COPD.",{"count":430,"type":21},18,[24],"This research study is for people who have been diagnosed with large B-cell lymphoma of the central nervous system (CNS), which has either returned or is not responding to current treatment. Goldcadomide is a new experimental drug that works by binding to a specific protein inside cancer cells and helps stimulate immune cells that help fight cancer cells. It also has the ability to enter the central nervous system. It has shown promising safety and effectiveness when combined with standard of care chemotherapy. Participants will be treated with this study drug combined with standard of care chemotherapy. Participation in the research will last about 2.5 years. The purpose of this study is to help researchers learn if the study drug, Golcadomide, in combination with the standard of care regimen is a safe and effective way to treat large B-cell lymphoma with CNS involvement.",[62,434],"Central Nervous System Lymphoma",[436,437,248,438],"Golcadomide","Pemetrexed","Dexamethasone","2026-05-20",{"date":441,"type":42},"2026-05-27",{"date":443,"type":21},"2026-06",{"date":445,"type":21},"2029-09",{"name":447,"class":49},"Allison Winter",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":50},"100519568","phase-2-phase-2-trial-of-epcoritamab-in-combination-with-rituximab-mini-cvp-for-older-unfitfrail-patients-or-anthracycline-ineligible-adult-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100519568","NCT06045247","Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit\u002FFrail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\nPatients must meet the following criteria for study entry:\n\n* Age ≥18 years\n* Histologically diagnosed\n* Diffuse large B-cell lymphoma, not otherwise specified (NOS) or\n* High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or\n* T cell\u002Fhistiocyte-rich large B-cell lymphoma\n* Have no prior systemic treatment for current lymphoma\n* Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following:\n* Age ≥80\n* Unfit\u002Ffrail by simplified geriatric assessment4\n* The link to calculate simplified geriatric assessment https:\u002F\u002Fredcap.filinf.it\u002Fsurveys\u002F?s=89AFXML8AK Criteria Fit Unfit Frail ADL ≥ 5 \\\u003C 5 6 \\\u003C 6 IADL ≥ 6 \\\u003C 6 8 \\\u003C 8 CIRS-G 0 score = 3-4\n\n  ≤ 8 score = 2 ≥ 1 score = 3-4 8 score = 2 0 score = 3-4 \\\u003C 5 score = 2 ≥ 1 score = 3-4\n\n  ≥ 5 score = 2 Age \\\u003C80 \\\u003C 80 ≥ 80 ≥ 80 Abbreviations: ADL, activities of daily living; IADL, instrumental ADL; CIRS-G, Cumulative Illness Rating Scale for Geriatrics\n* Ejection fraction (EF) \\\u003C50% but ≥30%\n* Needs to be asymptomatic or minimally symptomatic, New York Heart Association (NYHA) class 1 or 2\n* Previous cardiotoxic cancer treatment with anthracycline\n* Stage II bulky (\\>7cm), III or IV disease\n* Performance status ≤2 on the ECOG scale (PS ≤3 if attributed to lymphoma and improves to ≤2 by pre-phase treatment prior to enrollment)\n* Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \\> 1 cm in longest diameter by CT, PET\u002FCT, and\u002For MRI\n* Patients must have adequate organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL\\*\n\n  --\\*Growth factor permitted during screening\n* Platelet count ≥75 × 109\u002FL\n* Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin \\> 5)\n* AST and ALT ≤ 3x upper limit of normal (ULN)\n* Alkaline phosphatase \\\u003C 2.5 ULN\n* Creatinine clearance \\>45 ml\u002Fmin calculated by modified Cockcroft-Gault formula\n* All subjects must\n* Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.\n* Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.\n\nThe investigator is responsible for: ensuring that the patient understands the potential risks and benefits of participating in the study; ensuring that informed consent is given by each patient, this includes obtaining the appropriate signatures and dates on the informed consent document prior to the performance of any study procedures and prior to the administration of study treatment; answering any questions the patient may have throughout the study and sharing in a timely manner any new information that may be relevant to the patient's willingness to continue his or her participant in the trial. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. No one without capacity to personally consent will be enrolled. Patients have medical decision-making capacity if they can demonstrate understanding of the situation, appreciation of the consequences of their decision, and reasoning in their thought process, and if they can communicate their wishes.\n\nA determination of lack of decision-making capacity shall be made after an appropriate medical evaluation that concludes there is little or no likelihood that the participant will regain decision-making capacity in a reasonable period of time.\n\n* Females must agree to abstain from breastfeeding during study participation and for at least 12 months after epcoritamab discontinuation.\n* Females of childbearing potential (FCBP§) must:\n* Have one negative pregnancy tests via serum or urine prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, prior to day 1 of each cycle, and after end of study therapy. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n* Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice. Otherwise, she must agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting epcoritamab, during the study treatment (including dose interruptions), and for at least 12 months after the last dose of epcoritamab.\n* Male subjects must:\n* A male subject who is sexually active with a female with reproductive potential must agree to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F suppository (including dose interruptions), even if they have undergone a successful vasectomy, from the time of signing consent and for at least 12 months after the last dose of epcoritamab. A male subject must agree not to donate sperm or semen, while taking epcoritamab, during breaks (dose interruptions), and for at least 12 months after the last dose of epcoritamab.\n\nExclusion Criteria\n\nSubjects will be ineligible for this study if they meet any of following criteria:\n\n* Known central nervous system lymphoma or leptomeningeal disease\n* Suspicious case with symptoms should be evaluated with brain MRI with or without Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:\n* Adequately treated localized skin cancer without evidence of disease.\n* Adequately treated cervical carcinoma in situ without evidence of disease.\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.\n* Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2\n* Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n* History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n* History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.\n* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.\n* Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, 3rd degree block, 12-lead ECG showing a baseline QTcF \\>470 msec.\n* History of stroke, seizure disorder or patients requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.\n* Patients with more than mild pericardial effusion confirmed by ECHO.\n* Lactating or pregnant subjects\n* Administration of any investigational agent within 28 days of first dose of study drug.\n* Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.\n* Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \\\u003C 10 mg\u002Fday prednisone. For corticosteroids, prednisolone \\>20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma-related symptoms, including during screening, and for prophylaxis or AE management during the trial.\n* Life expectancy \\\u003C 6 months\n* Neuropathy \\> Grade 1\n* Prior exposure to epcoritamab, independently from indication\n* Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Patients who have a history of (non-infectious) pneumonitis that require steroids or has current pneumonitis.",{"count":126,"type":21},[59],"To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.",[62],"2026-05-18",{"date":439,"type":42},{"date":461,"type":42},"2024-01-05",{"date":463,"type":21},"2030-07-31",{"name":70,"class":49},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":50},"100474962","phase-2-a-phase-ii-study-of-loncastuximab-tesirine-as-consolidation-strategy-in-patients-with-lbcl-in-pr-after-car-t-cell-therapy-100474962","NCT05464719","A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy","Inclusion Criteria:\n\nEligible subjects will be considered for inclusion in this study if they meet the following criteria:\n\n1. Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma\n2. Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial\n3. ≥ 18 years of age\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy\n6. At least 30 days must have elapsed since CAR T-cell therapy infusion\n7. No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment\n8. No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy\n9. Absolute neutrophil count (ANC) of ≥ 1.0×109\u002FL without growth factor support for 3 days prior to screening assessment.\n10. Platelet count of ≥ 50×109\u002FL without transfusion for 3 days prior to screening assessment.\n11. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL\u002Fmin\n12. Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN)\n13. Total bilirubin ≤2 mg\u002FdL, except in subjects with Gilbert's syndrome.\n14. Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion\n15. Baseline oxygen saturation \\> 92% on room air\n16. No evidence or suspicion of lymphoma actively involving the central nervous system (CNS)\n17. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n18. Resolution of any previous CRS and\u002For ICANS to grade 0.\n\n4.3 Exclusion criteria\n\nSubjects will be ineligible for this study if they meet the following criteria:\n\n1. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n2. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at least 12 months\n3. History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n4. Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment\n5. Prior treatment with lonca\n6. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Principal investigator\n7. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of HIV, hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n8. Subjects with active cardiac atrial or cardiac ventricular lymphoma involvement\n9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment\n10. Primary immunodeficiency\n11. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring active systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n12. History of clinically significant deep vein thrombosis or pulmonary embolism within 1 month of enrollment per investigators discretion.\n13. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment\n14. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n15. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the PBD on the fetus or infant.\n16. Subjects of both genders who are not willing to practice birth control. Women of childbearing potential must use a highly effective method of contraception (hormonal birth control such as birth control pills, intravaginal ring, skin patch, implant or injection, intrauterine device or surgical sterilization) until 9 months after last dose of lonca, and men with female partners who are of childbearing potential should use a condom when sexually active until 6 months after the last dose of lonca\n17. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation Trial Treatments",{"count":356,"type":21},[59],"To learn if loncastuximab tesirine (called \"lonca\" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.",[62,302],{"date":439,"type":42},{"date":477,"type":42},"2022-09-23",{"date":479,"type":21},"2030-01-30",{"name":70,"class":49},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":50},"100637965","phase-2-lme-guided-precision-combination-therapy-in-b-cell-lymphoma-patients-after-cd19-car-t-failure-100637965","NCT07602322","LME-Guided Precision Combination Therapy in B-cell Lymphoma Patients After CD19 CAR-T Failure","An Exploratory, Two-Arm Study of LME Subtype-Guided Precision Combination Therapy Strategies in Patients With B-Cell Lymphoma After CD19 CAR-T Therapy Failure","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of gender.\n* Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL, not otherwise specified) or high-grade B-cell lymphoma.\n* Received prior CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.\n* Confirmed stable disease (SD) or progressive disease (PD) at the most recent imaging assessment (according to Lugano 2014 criteria) following CAR-T therapy.\n* Able to provide a formalin-fixed paraffin-embedded (FFPE) tumor tissue sample (fresh biopsy or archival specimen obtained before CAR-T therapy or after recent progression) with sufficient quantity and quality for immunohistochemistry (IHC) testing.\n* Confirmed CD20-positive tumor cells by central laboratory IHC testing.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate organ function (including bone marrow, liver, kidney, and heart).\n* Women of childbearing potential must agree to use highly effective contraception during the study and for a specified period after the last dose of study drug; male patients must agree to use effective contraception during the study and for a specified period after the last dose.\n* Voluntarily agreed to participate in the study, signed the written informed consent form, and willing to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Prior treatment with glofitamab resulting in disease progression.\n* Known severe allergic reactions to any components of the study drugs.\n* Active central nervous system (CNS) lymphoma involvement.\n* Presence of a severe, uncontrolled active infection.\n* Presence of severe cardiovascular or cerebrovascular diseases, uncontrolled diabetes, or uncontrolled hypertension that, in the investigator's judgment, makes the patient unsuitable for study participation.\n* History of or current other malignancies (exceptions: adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n* Pregnant or breastfeeding women.\n* Positive for human immunodeficiency virus (HIV) antibody, or active hepatitis B virus (HBV) infection (HBsAg positive with HBV-DNA \\> 1x10\\^3 copies\u002FmL), or active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA positive).\n* Any medical or psychiatric condition that might interfere with study execution or result interpretation, or place the patient at unacceptable risk.\n* Received other anti-tumor therapies (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study enrollment, or have not recovered from toxicities of prior therapies to ≤ Grade 1 or baseline levels (excluding alopecia or other irreversible but non-clinically significant toxicities).",{"count":489,"type":21},60,[59],"This study evaluates a personalized treatment strategy for patients with large B-cell lymphoma (LBCL) whose disease has relapsed or not responded after CD19 CAR-T cell therapy. Researchers believe that the area surrounding the tumor, called the lymphoma microenvironment (LME), plays a major role in why treatments fail.\n\nIn this study, researchers will classify patients into four different LME subtypes (GC, IN, ME, or DE) using a standard lab test on their tumor samples. Patients will then be randomly assigned to one of two groups. The control group will receive a standard single-drug therapy (glofitamab). The experimental group will receive a tailored combination therapy based specifically on their tumor's LME subtype. The main hypothesis of this study is that customizing the treatment based on the tumor's microenvironment will significantly improve how long patients live without their disease getting worse (progression-free survival) compared to the standard single-drug approach.",[62],[494,495,496],"Large B-Cell Lymphoma (LBCL)","CAR-T Failure","Lymphoma Microenvironment (LME)","2026-05-15",{"date":499,"type":42},"2026-05-22",{"date":501,"type":21},"2026-05-14",{"date":503,"type":21},"2028-11-01",{"name":142,"class":49},{"id":506,"slug":4,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":50},"100638003","NCT07599423","A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Signed Informed Consent Form.\n* Age 18 years or older at the time of signing the Informed Consent Form.\n* Histologically proven large B-cell lymphoma (LBCL), including transformation from follicular lymphoma.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles\u002Fprogression within 12 months) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of initiating first-line therapy).\n* No known history or suspicion of central nervous system (CNS) involvement by lymphoma.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.\n* Negative HIV test at screening.\n* Adequate hematologic function defined as hemoglobin 9.0 g\u002FdL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\\^9\u002FL or higher, and platelet count 75 x 10\\^9\u002FL or higher.\n* Adequate organ function defined as estimated creatinine clearance 60 mL\u002Fmin or higher, ALT\u002FAST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg\u002FdL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).\n* Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.\n* No clinically significant pleural effusion.\n* Baseline oxygen saturation greater than 92% on room air.\n* Able to understand and complete study-related questionnaires.\n* Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.\n\nExclusion Criteria:\n\n* Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Not eligible for autologous stem cell transplantation (ASCT).\n* Prior solid organ transplantation.\n* History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).\n* Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).\n* Prior radiotherapy to the mediastinal or pericardial region.\n* History of autologous or allogeneic stem cell transplant.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.\n* Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.\n* Received more than one line of therapy for DLBCL.\n* Corticosteroid use greater than 50 mg\u002Fday of prednisone or equivalent for purposes other than lymphoma symptom control.\n* Recent major surgery within 4 weeks before the first study treatment.\n* History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.\n* Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Current or past history of Waldenstrom macroglobulinemia.\n* History or presence of a clinically significant abnormal ECG.\n* Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.\n* History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.\n* History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.\n* Clinically significant liver disease, including active viral\u002Fother hepatitis or cirrhosis.\n* Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT\u002FaPTT greater than 1.5 x ULN.\n* Suspected active or latent tuberculosis.\n* Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.",{"count":512,"type":21},96,[59],"The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed\u002Frefractory large B-cell lymphoma (R\u002FR LBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).",[62],{"date":439,"type":42},{"date":518,"type":21},"2026-06-01",{"date":520,"type":21},"2030-12-31",{"name":522,"class":49},"The First Affiliated Hospital of Soochow University",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":50},"100596963","phase-1-nt-i7-efineptakin-alfa-a-long-acting-human-il-7-post-axicabtagene-ciloleucel-or-post-lisocabtagene-maraleucel-in-subjects-with-relapsedrefractory-large-b-cell-lymphoma-100596963","NCT07052305","NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed\u002FRefractory Large B-cell Lymphoma","A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed\u002FRefractory Large B-cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, DLBCL arising from an indolent lymphoma, grade 3B follicular lymphoma and primary mediastinal large B-cell lymphoma.\n* Measurable disease by IWG response criteria for lymphoma.\n\n  * Baseline FDG-PET\u002FCT scan must show FDG-avid lesions compatible with CT-defined anatomical tumor sites.\n  * A previously irradiated lesion can be considered a target lesion if it is well defined, measurable, and has clearly progressed following radiation.\n  * FDG-PET\u002FCT scans done as SOC up to 60 days pre-lymphodepletion therapy will be allowed. NOTE: After eligibility is confirmed, restaging FDG-PET\u002FCT scans will not be used to change eligibility.\n* Eligible for treatment with an FDA-approved SOC CD19 CAR T-cell therapy respective to the current FDA-approved CAR T-cell label for axi-cel(Yescarta®) or liso-cel (Breyanzi®).\n* If the patient has previously received an autologous stem cell transplant, s\u002Fhe must be at least 3 months post-transplant.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function at the start of lymphodepleting chemotherapy as pre-conditioning for SOC CD19 CAR T-cell infusion as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 50 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ IULN for patients with total bilirubin levels \\> 1.5 x IULN (except for patients with Gilbert's syndrome, who must have a baseline total bilirubin ≤ 3.0 mg\u002FdL)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN (except for patients with documented liver involvement or bone metastases, who must have an AST and\u002For ALT ≤ 5.0 x IULN)\n  * Alkaline phosphatase ≤ 2.5 x IULN (except for patients with liver metastasis, who must have an alkaline phosphatase ≤ 5.0 x IULN)\n  * Creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault\n  * INR and aPTT ≤ 1.5 x IULN unless the patient is receiving anticoagulant therapy and the PT or aPTT is within the therapeutic range for the anticoagulant. Patients who are on anticoagulation should be able to hold the anticoagulant for 4-5 half-lives of the anticoagulant prior to IM NT-I7 injection to reduce risk of hematoma.\n* ECG demonstrating Fridericia's corrected QT interval (QTcF) \\\u003C 500 ms; patients with QTcF ≥ 500 ms will require clearance by a cardiologist.\n* The effects of NT-I7 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days after the last NT-I7 injection. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Previous receipt of an allogeneic solid organ transplant or bone marrow transplant.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Chemotherapy or biologic or hormonal therapy for prior or concurrent cancer treatment, within 14 days prior to the first NT-I7 injection.\n\n  * NOTE: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable.\n* Currently receiving any other investigational agents, or received within 14 days prior to the first NT-I7 injection.\n* Documented active central nervous system (CNS) involvement by lymphoma.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to NT-I7 or other agents used in the study.\n* Presence of clinically significant, unresolved toxicities from prior anticancer therapy, defined as having not received to grade ≤ 1 (with the exception of alopecia and laboratory values listed per the inclusion criteria). Patients with irreversible toxicity that is not reasonably expected to be exacerbated by NT-I7 may be included (e.g., hearing loss, peripheral neuropathy) after consultation with the PI.\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection (including active hepatitis A or mycobacterium tuberculosis (testing not required))\n  * Congestive heart failure with NYHA Class ≥ 2\n  * Uncontrolled atrial fibrillation\n  * Any of the following within 6 months prior to day of CAR T-cell administration:\n\n    * Unstable angina pectoris\n    * Myocardial infarction\n    * Coronary artery bypass grafting\n    * Coronary angioplasty\n    * Coronary stenting\n    * Clinically significant cardiac arrhythmia and\u002For conduction abnormality\n  * Other clinically significant cardiac disease that, in the opinion of the treating physician and\u002For PI, is a contraindication to study treatment\n* History of autoimmune disease for the past 2 years prior to enrollment, including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  * NOTE: The following are exceptions to this criterion: vitiligo, alopecia, type 1 diabetes mellitus, autoimmune hypothyroidism stable on hormone replacement, psoriasis not severe enough to require systemic treatment, diverticulitis not associated with inflammatory bowel disease.\n* Contraindication to intramuscular therapy.\n* Receipt of a live, attenuated vaccine within 30 days prior to NT-I7 injection.\n\n  * NOTE: Patients, if enrolled, should not receive live vaccines during the study period and through 30 days after the last NT-I7 injection. The administration of inactivated vaccines is permitted at any time per the discretion of the treating physician.\n* Pregnant and\u002For breastfeeding and\u002For expecting to conceive or father children within the study duration (from enrollment through 90 days after last dose of NT-I7). Women of childbearing potential (including women who have had a tubal ligation) must have a negative serum or urine pregnancy test within 72 hours prior to CAR-T administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible.",{"count":531,"type":21},24,[24],"Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed\u002Frefractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed\u002Frefractory large B-cell lymphoma.\n\nIL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions.\n\nNT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo\u002Fradiotherapy and\u002For immune checkpoint inhibitors and CAR T therapy.\n\nThis study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed\u002Frefractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.",[62],[536,62,537,538,539,540,541,542,543],"Non-Hodgkins Lymphoma","Yescarta","Axi-cel","Breyanzi","Liso-cel","Interleukin 7","NT-I7","CD19 CAR T-cell Therapy","2026-05-08",{"date":546,"type":42},"2026-05-13",{"date":548,"type":42},"2026-03-12",{"date":550,"type":21},"2028-08-31",{"name":552,"class":49},"Washington University School of Medicine",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":570,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":50},"100507421","phase-1-feasibility-and-safety-of-collecting-and-combining-autologous-hematopoietic-stem-cells-with-chimeric-antigen-receptor-car-t-cell-therapy-in-subjects-with-relapsedrefractory-hematological-malignancies-100507421","NCT05887167","Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","IIT2022-04-Sasine-CAR-T: A Phase 1 Single-arm, Open-label Study to Evaluate the Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 - 85 years.\n* Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.\n* Relapsed or refractory disease, defined by the following:\n\n  * Disease progression after last regimen, or\n  * Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.\n* Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.\n* Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.\n* Eastern cooperative oncology group (ECOG) performance status 0 - 2.\n* Adequate hematologic, hepatic, and cardiac function\n* Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.\n* Willing to comply to research specimen collection as specified in the protocol.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.\n* History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, or any autoimmune disease with CNS involvement.\n* Doses of corticosteroids of greater than or equal to 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.\n* Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.\n* Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n* Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.","85 Years",{"count":562,"type":21},20,[24],"The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed\u002Frefractory (r\u002Fr) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r\u002Fr hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.",[566,62,567,568,569,158],"Hematologic Malignancy","Acute Lymphoblastic Leukemia","Mantle Cell Lymphoma","Multiple Myeloma",[571,572,94,573],"CAR T-cell therapy","autologous hematopoietic stem cells","CAR T therapy","2026-05-01",{"date":576,"type":42},"2026-05-07",{"date":578,"type":42},"2024-03-02",{"date":580,"type":21},"2027-12-15",{"name":582,"class":49},"Joshua Sasine, MD, PhD",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":591,"type":21},36,[24],"This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[595,596,568,297,298,597,598,218,599,413,600,601,158,62,602,603,604,605,606,607,608,609,610,36,611,612],"B Cell Lymphoma","NHL, Adult","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","Marginal Zone Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","High-grade B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","Waldenstrom Macroglobulinemia","Waldenstrom Macroglobulinaemia","2026-04-08",{"date":615,"type":42},"2026-04-14",{"date":617,"type":42},"2024-11-01",{"date":619,"type":21},"2028-12",{"name":621,"class":115},"Verismo Therapeutics",5,{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":50},"100574505","phase-2-tafasitamab-and-lenalidomide-as-first-salvage-therapy-for-residual-large-b-cell-lym-100574505","NCT06760156","Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym","Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel","Inclusion Criteria:\n\n* Patients must have histologically documented history of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n* Adult males or females must be of age ≥18 years or older at time of signing informed consent.\n* Patients must be capable of understanding the protocol with willingness to comply with all study procedures including availability for the duration of the study.\n* Patients must be able to understand and willing to sign a written informed consent form (ICF) document.\n* Measurable PET\u002FCT positive disease (partial response or stable disease per the 2014 Lugano Classification) on PET\u002FCT obtained at least 21 days after, but no more than 60 days after CAR-T with axicabtagene-ciloleucel.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants must have adequate organ and bone marrow function.\n* Patients must have adequate hepatic function.\n* Patients must have adequate renal function.\n* Baseline Oxygen Saturation \\>92% on room air.\n* Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning lenalidomide therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide therapy.\n\nExclusion Criteria:\n\n* Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible.\n* Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration.\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n* Presence of bacterial, viral, fungal, and\u002For other infection of any origin that is uncontrolled and\u002For requires intravenous (IV) antimicrobials for treatment.\n* Known cardiac atrial or cardiac ventricular lymphoma involvement.\n* History of symptomatic pulmonary embolism within 6 months of enrollment.\n* Known primary immunodeficiency.\n* History of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n* History of hypersensitivity, allergy or severe skin reactions to lenalidomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).\n* History of hypersensitivity, allergy or previous exposure to tafasitamab.\n* Any medical condition deemed by the treating physician likely to interfere with assessment of safety or efficacy of study treatment.",{"count":631,"type":21},28,[59],"The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.",[62],"2026-03-30",{"date":637,"type":42},"2026-04-03",{"date":639,"type":42},"2025-03-19",{"date":641,"type":21},"2028-01",{"name":643,"class":49},"H. Lee Moffitt Cancer Center and Research Institute",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":50},"100524121","phase-2-single-arm-comprehensive-ablative-bridging-irradiation-i-prior-to-cd19-car-t-in-high-risk-rr-lbcl-100524121","NCT06104592","Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R\u002FR LBCL","Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease","Inclusion Criteria:\n\n* Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center will be eligible.\n* Must have ability to comprehend and the willingness to sign written informed consent for study participation.\n* Eligible to receive CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and histological variants approved by the standard of care label\n* ECOG performance status 0 to 2.\n* At least one high-risk lesion, defined as measuring ≥ 5 cm, that is targetable for radiotherapy per investigator assessment.\n* Ability to undergo comprehensive bridging radiation, defined as radiation to all visible sites of disease.\n* No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma\n* Adequate bone marrow and organ function as defined in protocol.\n\nThe effects of therapeutic agents used in this trial on developing human fetus are unknown, and because of this, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as outlined in criteria below:\n\n* Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants in their understanding confirmed.\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Patients must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n* Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and\u002For bilateral oophorectomy OR ≥12 months of amenorrhea) are eligible.\n\nExclusion Criteria:\n\n* Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible\n* Prior treatment with chimeric antigen receptor (CAR) T-cell therapy\n* Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion\n* Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and circulatory collapse requiring vasopressor or inotropic support.\n* Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.\n* Evidence of active uncontrolled\u002Funtreated infection (viral, bacterial, fungal, opportunistic) of any origin.\n* Known positive Human immunodeficiency virus (HIV) status.\n* Participants with evidence of active and\u002For chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection, HCV must have a negative nucleic acid test post-treatment or spontaneous clearance.\n* Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (Section 6.6) are allowed after leukapheresis.\n* Any condition that would, in the investigator's judgement, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation including ability to safely undergo radiation treatment planning and delivery.\n* Women of childbearing potential who are pregnant or breastfeeding. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential.",{"count":652,"type":21},27,[59],"This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.",[62,297],{"date":657,"type":42},"2026-03-31",{"date":659,"type":42},"2023-11-08",{"date":661,"type":21},"2026-12",{"name":643,"class":49},{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":17,"minAge":670,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":682,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":693},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":673,"type":21},32,[24,59],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[677,62,678,240,599,218,568,158,601,679,604,680,681],"B-cell Acute Lymphoblastic Leukemia","Chronic Lymphocytic Leukemia","Burkitt Lymphoma","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[683,684,302],"CD19-positive","Leukemia","2026-03-24",{"date":635,"type":42},{"date":688,"type":42},"2025-05-30",{"date":690,"type":21},"2031-09",{"name":692,"class":115},"Vironexis Biotherapeutics Inc.",9]