[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-high-grade-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-high-grade-b-cell-lymphoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,86,116,140,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100536917","phase-2-golcadomide-post-car-t-cell-in-rr-aggressive-large-b-cell-lymphoma-patients-with-high-risk-of-relapse-100536917",false,"NCT06271057","Golcadomide Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Golcadomide (BMS-986369) Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Inclusion Criteria:\n\n1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted\n2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)\n3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells\n4. Performance Status 0, 1, or 2\n5. With aggressive large B-cell lymphoma, including:\n\n   * diffuse large B-cell lymphoma\n   * Primary mediastinal B-cell lymphoma\n   * Any transformed follicular or marginal zone lymphoma\n   * high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma\n6. Available biopsy for centralized review\n7. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment\n8. Total MetabolicTumor Volume (TMTV) \\> 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +\u002F- 4 days before lymphodepletion)\n9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \\> 60-year-old or Cockcroft-Gault if \\\u003C60yo) \\>45 mL\u002Fmin,\n10. Adequate hepatic function:\n\n    * aspartate aminotransferase\u002Falanine aminotransferase (ALT\u002FAST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT\u002FAST must be ≤ 5.0 x ULN)\n    * Serum total bilirubin ≤ 2.0 mg\u002FdL (34 μmol\u002FL) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg\u002FdL (51 μmol\u002FL))\n11. Patient covered by any social security system (France)\n12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators\n13. Contraception:\n\n    * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years\n2. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor\n3. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines\n4. Significant pulmonary function impairment and oxygen saturation (SaO2) \\\u003C 92% on room air\n5. Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n8. Current treatment with strong CYP3A4\u002F5 modulators (see appendix 13)\n9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential\n10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)\n11. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n12. Person hospitalized without consent\n13. Adult person under legal protection","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.\n\nApproximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.\n\nThe duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.\n\nThe primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.",[26,27,28,29],"Diffuse Large B-cell Lymphoma Refractory","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed B-cell Non-Hodgkin Lymphoma","Refractory High Grade B-Cell Lymphoma",[31],"eligible for CAR T-cells therapy","RECRUITING","2026-06-02",{"date":35,"type":36},"2026-06-04","ACTUAL",{"date":38,"type":36},"2024-06-14",{"date":40,"type":20},"2028-12-31",{"name":42,"class":43},"The Lymphoma Academic Research Organisation","OTHER",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100471377","phase-1-genetically-engineered-cells-anti-cd19cd20cd22-car-t-cells-for-the-treatment-of-relapsed-or-refractory-lymphoid-malignancies-100471377","NCT05418088","Genetically Engineered Cells (Anti-CD19\u002FCD20\u002FCD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies","Phase I Clinical Trial of Anti-CD19\u002F20\u002F22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, B-Prolymphocytic Leukemia)","Inclusion Criteria:\n\n* Adult subjects with relapsed or refractory non-Hodgkin lymphoma with lesions =\\\u003C 5 cm, indolent lymphomas, chronic lymphocytic leukemia without Richter's transformation, or B-prolymphocytic leukemia (Cohort A)\n* OR adult subjects with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions \\> 5 cm and\u002For lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells, B-Prolymphocytic leukemia with lesions \\> 5 cm (not including splenomegaly (Cohort B).\n* OR Pediatric subjects with Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma\n* Subjects must have been treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen. B-PLL is defined as having greater than 55% prolymphocytes in the peripheral blood\n* Subjects with relapsed\u002Frefractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor and venetoclax\n* Subjects with refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant\n* Subjects with relapsed\u002Frefractory B-prolymphocytic leukemia who received at least 1- 2 prior lines of appropriate therapy and who have failed or are ineligible for allogeneic stem cell transplant\n* Subjects with relapsed\u002Frefractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy or who have failed or are ineligible for allogeneic stem cell transplant.\n* The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and\u002For CD20 and\u002For CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.\n* Patients who received blinatumomab or inotuzumab are eligible.\n* Patients who received prior CAR T-cells are eligible, (commercial CD 19 CAR-T cells or dual CAR-T cells), if it has been at least 30 days since previous CAR T cell therapy and \\\u003C5% of circulating levels of CD3+ cells express the prior CAR by flow cytometry.\n* Age \\>= 2 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2. For patients \\\u003C 16 years, Performance score Lansky \\>= 50\n* Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal for age\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3 X institutional upper limit of normal for age\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 X institutional upper limit of normal for age\n* Creatinine clearance more than or equal to 50 ml\u002Fmin calculated by the Cockcroft - Gault formula, or by Schwartz formula for patients \\\u003C 18 years\n* Subjects must have adequate pulmonary function as defined as pulse oximetry \\>= 92% on room air\n* Subjects must have adequate cardiac function as defined as left ventricular ejection fraction \\>= 40% in the most recent echocardiogram\n* Absolute lymphocyte count \\> 100\u002FuL\n* Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the Anti-CD19\u002F20\u002F22 CAR-T cell infusion\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 and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive s that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\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* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\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 6 months after the Anti-CD19\u002F20\u002F22 CAR-T cell infusion. 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 6 months after the human anti-CD19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. 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* Autologous transplant within 6 weeks of planned CAR-T cell infusion\n* Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents. Patients with live vaccines given 28 days prior to lymphodepletion (LD) chemotherapy will be excluded\n* Active graft versus host disease\n* Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases\u002Fcentral nervous system (CNS) disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 90 days prior to registration\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g.cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g.\n\nLow Gleason score prostate Cancer)\n\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection\n* Human immunodeficiency virus (HIV)-seropositive patients are allowable, however must be on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment to be eligible for this trial\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Patients with a positive hepatitis B core antibody or surface antigen are at high risk for hepatitis B virus (HBV) reaction and will require entecavir\u002Ftenofivir prophylaxis or serial hepatitis B (Hep B) PCR monitoring at the direction of an infectious disease specialist. Duration of prophylaxis to correspond with detection of Anti-CD19\u002F20\u002F22 CAR T cells\u002Fviral vector copies in serum or continued evidence of B-cell aplasia such as reduced intravenous immunoglobulin therapy (IVIG) levels. No antiviral prophylaxis is indicated with hepatitis C positivity with negative PCR\n* Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months\n* Live vaccines given in 28 days prior to lymphodepleting chemotherapy","2 Years",{"count":54,"type":20},54,[56],"PHASE1","This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19\u002FCD20\u002FCD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19\u002FCD20\u002FCD22 which are found on the surface of cancer cells. Anti-CD19\u002FCD20\u002FCD22 CAR T-cells can recognize CD19\u002FCD20\u002FCD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.",[59,60,61,62,63,64,65,66,67,68,69,70,29,71,72,73,74,75],"Recurrent Acute Lymphoblastic Leukemia","Recurrent B Acute Lymphoblastic Leukemia","Recurrent B-Cell Prolymphocytic Leukemia","Recurrent Chronic Lymphocytic Leukemia","Recurrent High Grade B-Cell Lymphoma","Recurrent Indolent Non-Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia","Refractory B-Cell Prolymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Indolent Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","Refactory Childhood Acute Lymphoblastic Leukemia","Refractory Childhood Non-Hodgkin Lymphoma","2026-05-27",{"date":78,"type":36},"2026-05-29",{"date":80,"type":36},"2022-06-30",{"date":82,"type":20},"2027-07-01",{"name":84,"class":43},"Sumithira Vasu",2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100490909","phase-2-loncastuximab-tesirine-and-mosunetuzumab-for-the-treatment-of-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100490909","NCT05672251","Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n* Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Life expectancy \\> 12 months.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma Grade 3B according to the WHO classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Relapsed or refractory disease after \\>= 1 prior line of therapy (prior CD19-directed therapy and prior autologous stem cell transplant are allowed).\n\n  * Relapse at the time of study enrollment must have been confirmed histologically (with hematopathology review at the participating institution). Exceptions may be granted with study PI approval.\n* Measurable disease by computerized tomography (CT) or positron emission tomography (PET)\u002FCT scan with one or more sites of disease \\>= 1.5 cm in longest dimension.\n* Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C Grade 1 to prior anti-cancer therapy\n* Without bone marrow involvement: Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* With bone marrow involvement: no minimum ANC requirement.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* Platelets \\>= 75,000\u002Fmm\\^3.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN).\n\n  * If hepatic involvement by lymphoma, or Gilbert's disease: =\\\u003C 3X ULN.\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: AST =\\\u003C 5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: ALT =\\\u003C 5 x ULN .\n* Creatinine clearance of \\>= 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =\\\u003C 1.5 x ULN.\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants.\n* If not receiving anticoagulants: Activated Partial Thromboplastin Time (aPTT) =\\\u003C 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females of childbearing potential to abstain from heterosexual intercourse or use two adequate method of birth control, including at least 1 method with a failure rate of \\\u003C 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), until 3 months after the final dose mosunetuzumab and 9 months after the last dose of loncastuximab tesirine. Women must refrain from donating eggs during this same period. Agreement by males to abstain from heterosexual intercourse or use a condom with female partners of childbearing potential or pregnant female partners during the treatment period and for 3 months after the final dose of mosunetuzumab and 6 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only) with no identified cause other than menopause.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established and proper use of progestogen only hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices. Barrier methods must always be supplemented with the use of a spermicide. Note: Combined oral contraceptives are not recommended.\n\nExclusion Criteria:\n\n* Prior treatment with loncastuximab tesirine.\n* Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.\n* Prior allogeneic stem cell transplantation.\n* Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy.\n* Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.\n\n  * If patients have received radiotherapy within 4 weeks prior to prior to Day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.\n* Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.\n* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.\n* Live vaccine within 30 days prior to Day 1 of protocol therapy.\n* Concomitant investigational therapy.\n* Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents(e.g., immune checkpoint inhibitor therapies). Note: For certain prior treatments, such as CAR-T cell therapies, patients with prior immune-related Grade \\>= 3 adverse events (e.g., CRS) may be allowed after discussion with and approval by the Study PI.\n* Systemic steroid therapy or any other form of immunosuppressive therapy for lymphoma symptom control must be tapered down to =\\\u003C 20 mg\u002Fday prednisone or equivalent. Exceptions are:\n\n  * Inhaled or topical steroids\n  * Use of mineralocorticoids for management of orthostatic hypotension\n  * Use of physiologic doses of corticosteroids for management of adrenal insufficiency\n* Known hypersensitivity to biopharmaceutical produced in chinese hamster ovary (CHO) cells or history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.\n* 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).\n* History of solid organ transplantation.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Clinically significant uncontrolled illness.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Testing to be done only in patients suspected of having infections or exposures.\n* Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \\> 200 and are on HAART medication are allowed. Testing to be done only in patients suspected of having infections or exposures.\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection.\n* Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement.\n* History of erythrema multiforme, Grade \\>= 3 rash, or blistering following prior treatment with immunomodulatory derivatives.\n* Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event\u002Fstroke or myocardial infarction within the past 6 months.\n* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.\n* Active autoimmune disease requiring treatment.\n* History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible.\n* Recent major surgery (within 4 weeks) prior to start of protocol therapy, other than for diagnosis.\n* History of another primary malignancy that has not been in remission for at least 2 years, with the following exceptions:\n\n  * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\n  * Adequately treated in situ carcinomas (e.g. cervical, esophageal) without evidence of disease\n  * Asymptomatic prostate cancer managed with a watch-and-wait strategy\n  * If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI).\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":94,"type":20},36,[23],"This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.",[98,99,63,100,66,101,102,103,29,104,73,105],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Grade 3b Follicular Lymphoma","Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-07",{"date":108,"type":36},"2026-05-11",{"date":110,"type":36},"2024-01-02",{"date":112,"type":20},"2027-03-23",{"name":114,"class":43},"City of Hope Medical Center",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":115},"100576394","phase-2-odronextamab-for-relapsed-and-refractory-large-b-cell-lymphomas-before-car-t-100576394","NCT06784726","Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T","Odronextamab for Relapsed\u002FRefractory Large B-Cell Lymphomas Before Definitive Lymphoma-Directed Therapies","Inclusion Criteria:\n\n* Histologically confirmed 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, DLBCL arising from indolent lymphoma, follicular lymphoma (FL) grade 3B\n* Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening, according to the International Working Group consensus response evaluation criteria in lymphoma\n* Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel) per Food and Drug Administration (FDA) label\n* Age ≥ 18 years\n* Capable of understanding and providing a written informed consent\n* Prior treatment with an anti-CD20 antibody therapy\n* Eastern Cooperative Oncology Group performance status of 0-1; we allow enrollment of patients with a performance status of 2 if it is attributed to lymphoma per discretion of the treating physician or principal investigator (PI)\n* Creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault equation\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the ULN\n* Adequate pulmonary function, defined as ≤ grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% on room air\n* Adequate cardiac function, defined as left ventricular ejection fraction ≥ 50% and without evidence for pericardial effusion\n* Platelet count ≥ 75 x 10\\^9 \u002FL\n* Hemoglobin (Hg) level ≥ 9 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Platelet count ≥ 25 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Hg ≥ 7.0 g\u002FdL\n* Patients with bone marrow involvement or splenic sequestration: ANC ≥ 0.5 x 10\\^9 \u002FL\n* Negative serum pregnancy test within 2 days of initiating odronextamab for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year\n* Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the CAR T-cell infusion\n* Patients must not provide egg or sperm donation until at least 6 months after the completion of the last dose of Odron\n\nExclusion Criteria:\n\n* Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. Patients with a history of secondary central nervous system (CNS) lymphoma may be eligible provided that there has been no evidence of CNS disease from lymphoma for at least 3 months at the time of screening\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n* Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first administration of study drug\n* Standard radiotherapy within 2 weeks of first administration of study drug\n* Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy, unless all the following are met: disease responded to prior bispecific therapy (CR or PR per Lugano criteria) and did not experience disease progression within 12 months of the last dose of prior bispecific therapy, and the tumor must still express CD20 (CD20 examination per standard of care \\[SOC\\])\n* Allogeneic stem cell transplantation\n* Any CAR-T cell therapy\n* Patients may not be receiving other investigational agents\n* Treatment with rituximab, alemtuzumab, or other investigational or commercial biologic agent within 2 weeks prior to first administration of study drug\n* Immunosuppressive therapy (other than biologic) within 2 weeks of first administration of study drug\n* Treatment with an investigational non-biologic agent within 2 weeks of first administration of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition of study drug\n* History of hypersensitivity to any compound in the tetracycline antibiotics group\n* Concurrent active malignancy for which the patient is receiving systemic treatment, unless approved by PI\n* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection\n* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and\u002For significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm)\n* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg\u002Fday of prednisone or equivalent. A short course of corticosteroid for lymphoma disease control during screening is allowed\n* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 400) or chronic infection with hepatitis B virus or hepatitis C virus. Patients with hepatitis B (hepatitis B surface antigen positive \\[HepBsAg+\\]) with controlled infection were permitted upon consultation with the physician managing the infection\n* Known hypersensitivity to both allopurinol and rasburicase\n* Pregnant or breast-feeding women\n* Administration of live vaccination within 28 days of first administration of study drug",{"count":124,"type":20},27,[23],"This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.",[98,128,99,63,129,101,102,130,103,29,27,105],"Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","2026-05-04",{"date":133,"type":36},"2026-05-06",{"date":135,"type":36},"2025-09-04",{"date":137,"type":20},"2033-04-11",{"name":139,"class":43},"University of Washington",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":5},"100445214","phase-1-immune-cell-therapy-car-t-for-the-treatment-of-patients-with-hiv-and-b-cell-non-hodgkin-lymphoma-100445214","NCT05077527","Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma","Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Participant with age \\>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \\\u003C 18 years of age, children are excluded from this study\n* Participant is able to understand and willing to sign a written informed consent document before any study procedures\n* Participant must have R\u002FR aggressive B-cell NHL of the following histologies:\n\n  * Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)\n  * High-grade B-cell lymphoma\n  * Primary mediastinal B-cell lymphoma\n  * Follicular lymphoma, grade 3B\n* Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R\u002FR disease after at least 2 lines of therapy\n\n  * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent\n* Evaluable disease as either:\n\n  * Positron emission tomography (PET)-positive disease according to the \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\", or\n  * Bone marrow involvement assessed by bone marrow biopsy\n* Eastern Cooperative Oncology Group ECOG performance status =\\\u003C 1 (Karnofsky \\>= 60%)\n* Serum creatinine =\\\u003C 1.5 x age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2 (within 4 weeks before enrollment)\n* Alanine aminotransferase (ALT) =\\\u003C 5 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4 weeks before enrollment)\n* Adequate pulmonary function, defined as =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) grade 1 dyspnea and oxygen saturation (SaO2) \\>= 92% on room air (within 4 weeks before enrollment)\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of eligibility\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Total bilirubin: =\\\u003C 1.5 x institutional upper limit of normal (ULN) (3.0 x ULN for patients with Gilbert syndrome) If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\\\u003C 3.5 mg\u002FdL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and ALT =\\\u003C 3 x the upper limit of normal (within 4 weeks before enrollment)\n* Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)\n* Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy\n* The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 12 months after the last dose of axicabtagene ciloleucel. 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 who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene ciloleucel\n* Documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care investigator;\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\]) by a licensed health care investigator. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL;\n\n    * Any federally approved, licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: A \"licensed\" assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies\n* HIV viral load below 50 copies\u002FmL by FDA-approved assays within 4 weeks prior to registration\n* A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 \\\u003C100 cells\u002FuL\n* Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and\u002For anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\\\u003C 1.5 x institutional upper limit of normal (ULN), AST (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and ALT (serum glutamic pyruvic transaminase \\[SGPT\\]) must be =\\\u003C 3 X institutional upper limit of normal, and HBV deoxyribonucleic acid (DNA) \\\u003C100 IU\u002FmL (if hepatitis B positive) within 4 weeks before enrollment. There must be no evidence of cirrhosis present\n* Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion\n* Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel\n\nExclusion Criteria:\n\n* Participants felt to have a high prospect of clinically benefiting from autologous transplantation\n* Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study\n* Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis\n* Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment\n* Presence of acute or chronic graft-versus-host disease\n* History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n* Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study because axicabtagene ciloleucel has not been studied in pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with axicabtagene ciloleucel, breastfeeding should be discontinued if the mother is treated with axicabtagene ciloleucel. These potential risks may also apply to other agents used in this study\n* Use of the following:\n\n  * Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted\n  * Chemotherapy given after leukapheresis to maintain disease control must be stopped \\>= 7 days before conditioning chemotherapy\n  * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis\n  * Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis\n  * Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis\n  * Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R)\n  * Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration\n  * Radiation within 1 week before leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks before leukapheresis\n  * Prior receipt of CAR T-cell therapy\n* Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:\n\n  * Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced magnetic resonance imaging (MRI) within 2 weeks before leukapheresis and no neurologic progression prior to axicabtagene ciloleucel (axi-cel) infusion\n  * Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a total spine and brain gadolinium enhanced MRI within 5 days before axi-cel infusion to document the extent of CNS disease prior to axi-cel infusion. Cerebrospinal fluid (CSF) sampling for cell count, cytology and cell markers by flow cytometry should also be included within 5 days of axi-cel infusion if previously positive\n* Inhaled or topical steroids and adrenal replacement doses =\\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, including if \\>= 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. Use of anabolic steroids is permitted\n* The participant has not recovered to baseline or CTCAE =\\\u003C grade 1 from toxicity due to all prior therapies except =\\\u003C grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided that all other eligibility criteria are met\n* Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements",{"count":148,"type":20},20,[56],"This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.",[152,153,154,98,99,63,65,100,155,102,103,29,72,104,156],"AIDS-Related Diffuse Large B-cell Lymphoma","AIDS-Related Non-Hodgkin Lymphoma","HIV Infection","Recurrent Transformed B-Cell Non-Hodgkin Lymphoma","Refractory Transformed B-Cell Non-Hodgkin Lymphoma","2026-04-09",{"date":159,"type":36},"2026-04-14",{"date":161,"type":36},"2025-02-13",{"date":163,"type":20},"2029-01-31",{"name":165,"class":166},"AIDS Malignancy Consortium","NETWORK",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":115},"100600505","phase-1-st-067-in-combination-with-cd19-directed-car-t-cell-therapy-liso-cel-in-relapsedrefractory-large-b-cell-lymphoma-100600505","NCT07098364","ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1\u002F2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed\u002FRefractory (R\u002FR) Large B-Cell Lymphoma (LBCL)","Inclusion Criteria:\n\n* Male or female \\>= 18 years of age at the time of consent\n* Patients with LBCL (including diffuse large B-cell lymphoma \\[DLBCL\\] not otherwise specified \\[including DLBCL arising from indolent lymphoma\\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 lines of systemic therapy and an Food and Drug Administration (FDA)-approved indication for treatment with liso-cel\n* Fluorodeoxyglucose (FDG)-avid disease on PET imaging before lymphodepletion or pathology evidence of active disease\n* Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology\n* Karnofsky performance status \\>= 60%\n* Adequate bone marrow function for lymphodepletion chemotherapy defined as: absolute neutrophil count (ANC) \\>= 1000 cells\u002Fmm\\^3, platelets \\>= 50,000 cells\u002Fmm\\^3, and hemoglobin \\>= 8 g\u002FdL, unless the cytopenias are due to bone marrow involvement by lymphoma in the opinion of the principal investigator (PI)\n* Calculated creatinine clearance (Cockcroft\u002FGault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (or \\\u003C 5 x ULN for subjects with lymphomatous infiltration of the liver) and total bilirubin =\\\u003C 2 (or \\\u003C 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis)\n* Adequate pulmonary function based on pulmonary function testing (PFT), defined as forced expiratory volume in 1 second (FEV1) and FEV1\u002Fforced vital capacity (FVC) ratio of \\>= 60% of predicted value and diffusing capacity of the lung for carbon monoxide (DLCO; corrected) \\>= 40% of predicted value\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA)\n* Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for at least 30 days after the last dose of study therapy (ST-067)\n* Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method for at least 90 days after the last dose of study therapy (ST-067)\n* Ability to understand and provide informed consent\n* Able and willing to comply with study visit schedule and procedures, including tumor biopsy where feasible and with acceptable risk\n\nExclusion Criteria:\n\n* Planned use of out-of-specification liso-cel product\n* History of another malignancy. The following are exceptions to this criterion:\n\n  * Adequately treated basal cell or squamous cell carcinoma of the skin.\n  * In situ prostate, ductal breast carcinoma breast, and cervical carcinoma.\n  * Adequately treated papillary, noninvasive bladder cancer.\n  * Other adequately treated stage 1 or 2 cancers currently in complete remission.\n  * Any other cancer that has been in remission for \\>= 2 years\n* Planned use of therapeutic doses of corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to liso-cel infusion. Topical and\u002For inhaled steroids are permitted\n* Prior treatment with any CD19 CAR T-cell therapy\n* For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and\u002For systemic GVHD therapy within 30 days prior to planned leukapheresis\n* Known active hepatitis B (detectable hepatitis B deoxyribonucleic acid \\[DNA\\]) or hepatitis C (detectable hepatitis C ribonucleic acid \\[RNA\\])\n* Known human immunodeficiency virus (HIV) infection\n* Pregnant or breastfeeding women\n* Prior treatment with any IL-1 or IL-18 agonist and\u002For biosimilar agents, or an investigational agent within 4 weeks or 5 half-lives, whichever is shorter, prior to start of lymphodepletion\n* Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis, Crohn's disease\\], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome \\[granulomatosis with polyangiitis\\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) requiring immunosuppressive therapy. The following are exceptions to this criterion:\n\n  * Vitiligo.\n  * Alopecia.\n  * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Type 1 diabetes mellitus.\n  * Psoriasis not requiring systemic treatment.\n  * Conditions considered to be low risk of serious deterioration by the PI\n* History of any one of the following cardiovascular conditions within the past 6 months, unless clearance by a cardiologist is obtained: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina. History of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to study treatment is also excluded\n* Significant electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular (AV) block type II, third-degree AV block, \\>= grade 2 bradycardia, or QT interval corrected using Fridericia's formula \\> 500 ms irrespective of gender\n* History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the PI is a contraindication to study treatment.\n\n  * Patients with active parenchymal CNS involvement by malignancy will be excluded. Patients with prior or current secondary leptomeningeal CNS disease are eligible. CNS disease prophylaxis must be stopped at least 1 week prior to liso-cel infusion\n* History of solid organ transplantation\n* Active, serious, and uncontrolled infection(s)",{"count":175,"type":20},33,[56,23],"This phase I\u002FII trial tests the safety, side effects, and best dose\u002Fregimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed\u002Frefractory LBCL.",[98,128,99,179,180,129,102,130,103,181,182,27],"Recurrent High-Grade B-Cell Lymphoma","Recurrent Indolent B-Cell Non-Hodgkin Lymphoma","Refractory High-Grade B-Cell Lymphoma","Refractory Indolent B-Cell Non-Hodgkin Lymphoma","2026-01-13",{"date":185,"type":36},"2026-01-14",{"date":187,"type":36},"2025-12-27",{"date":189,"type":20},"2043-10-04",{"name":191,"class":43},"Fred Hutchinson Cancer Center"]