[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-mediastinal-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-mediastinal-large-b-cell-lymphoma":190},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,51,81,109,131,176,203,230,253,280,301,331,354],{"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":36,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100404393","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-100404393",false,"NCT04545762","Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","THE DOSE ESCALATION COHORT IS CLOSED TO FURTHER ENROLLMENT.\n\nInclusion Criteria:\n\nDose expansion Cohorts:\n\nCohort B (Burkitt):\n\n1. Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma\n\n   * Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.\n   * No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells.\n2. Participants must have measurable disease as defined below:\n\n   * Participants with Burkitt Lymphoma must have Positron Emission Tomography (PET)-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\"\n\nCohort M\u002FW (Marginal\u002FWaldenström):\n\n1. Participants must have a diagnosis of relapsed or refractory Marginal Zone Lymphoma (MZL), or Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenström Macroglobulinemia (WM):\n\n   o Participants with indolent lymphomas (nodal or extranodal marginal zone lymphoma, and lymphoplasmacytic lymphoma) must have relapsed after or have been refractory to ≥ 2 prior lines of multi-agent chemoimmunotherapy including prior exposure to an anti-CD20 antibody and an alkylating agent.\n2. Participants must have measurable disease as defined below:\n\n   o Participants with Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia: must either have PET-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\" or serum monoclonal immunoglobulin M (IgM) paraprotein \\> 0.5 g\u002FdL.\n3. Participants with indolent lymphoma (Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia) must have symptomatic disease or steady progression necessitating systemic treatment per investigator discretion.\n\nIn addition, all participants must meet the following criteria:\n\n1. CD19-positive by either immunohistochemistry or flow cytometry analysis on any biopsy. If prior anti-CD19 therapy has been administered, CD19-positivity has to be re-established on the most recent biopsy.\n2. Age ≥18 years at the time of consent.\n3. Absolute lymphocyte count \\> 100\u002FUL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2.\n5. Adequate organ function, defined as:\n\n   1. Adequate bone marrow function for apheresis and lymphodepleting chemotherapy\n   2. Hemoglobin \\>8 gm\u002Fdl (transfusions allowed)\n   3. Platelets \\>50,000\u002FuL (transfusions allowed)\n   4. Absolute Neutrophil Count (ANC) \\> 500\u002FuL\n   5. alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\\u003C 3 x institutional upper limit of normal (ULN) and Total bilirubin \\\u003C 1.5 mg\u002Fdl x institutional ULN, except with Gilbert's syndrome\n   6. Serum Creatinine \\\u003C 2 x the institutional ULN\n   7. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\> 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) within 3 months of screening. Repeat testing may occur at Investigator's discretion.\n6. Adequate vascular access for leukapheresis procedure (either peripheral line or surgically placed line).\n7. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-CD19 CAR-T cells.\n8. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method.\n9. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 weeks of planned CAR-T cell infusion.\n2. Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.\n3. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast).\n4. Human immunodeficiency virus (HIV) seropositivity.\n5. Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded.)\n6. Participants 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.\n7. 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. 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. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test.\n8. Participants with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n9. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n10. Body weight \\\u003C40 kilograms(kg).\n\nEligibility for Infusion of Investigational Product:\n\nParticipants will undergo an evaluation of eligibility on day 1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions:\n\n1. No significant laboratory abnormalities. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition.\n2. ECOG performance status \\\u003C 2\n3. No evidence of uncontrolled intercurrent illness including, but not limited to ongoing or active infection, inflammatory response, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations.\n4. No new neurologic symptoms suggestive of an active central nervous system condition, or uncontrolled CNS involvement by lymphoma.\n5. No corticosteroid use within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).",[26,27,28,29,30,31,32,33,34,35],"Refractory Non-Hodgkin Lymphoma","Burkitt Lymphoma","Mantle Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Diffuse Large B Cell Lymphoma","Small Lymphocytic Lymphoma","Transformed Lymphoma","Non-Hodgkin Lymphoma",[37],"CAR-T Therapy","RECRUITING","2026-06-17",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2020-09-11",{"date":46,"type":20},"2026-10-31",{"name":48,"class":49},"C. Babis Andreadis","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":50},"100600428","phase-2-epcoritamab-with-dose-adjusted-etoposide-cyclophosphamide-vincristine-doxorubicin-prednisone-and-rituximab-epoch-r-for-the-treatment-of-aggressive-b-cell-non-hodgkin-lymphoma-100600428","NCT07097363","Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma","A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. 1 prior cycle of chemoimmunotherapy may be allowed. Composite lymphomas are not excluded provided that the subject has not received prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:\n\n  * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocations\n  * High grade B-cell lymphoma, not otherwise specified (NOS)\n  * Diffuse large b-cell lymphoma (DLBCL) NOS\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte-rich large-B-cell lymphoma\n  * Epstein Barr virus (EBV) + DLBCL, NOS\n  * Burkitt lymphoma\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n* Be willing and able to provide written informed consent for the trial\n* Be ≥ 18 years of age on day of signing informed consent\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on CT or FDG-PET\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS) at time of enrollment\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL except in cases of marrow infiltration by lymphoma\n* Platelets ≥ 75,000 \u002F mcL except in cases of marrow infiltration by lymphoma or hypersplenism\n* Hemoglobin ≥ 8 g\u002FdL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment\n* Measured or calculated\\* creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine clearance \\[CrCl\\]) ≥ 45 mL\u002Fmin\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin ≤ 3.0 x ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants or prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≤ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of ≤ 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 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 post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last treatment. Men must refrain from donating sperm during this same period. 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 preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of EPOCH-R, including, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (400 mg\u002Fm\\^2)\n* Prior systemic treatment for lymphoma. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response\n* Transformation from indolent lymphoma is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion\n* Prior organ transplantation\n* Current grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* Prior systemic therapy for indolent lymphoma\n* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids and\u002For 1 cycle of chemoimmunotherapy in the following manner:\n\n  * Up to 30 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment). If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll. A maximum of 1 cycle of chemoimmunotherapy is allowed if needed for urgent disease stabilization if patient had staging PET\u002FCT and LVEF evaluation prior to chemoimmunotherapy; in this situation patients will receive therapy on study starting with cycle (C)1 day (D)8 epcoritamab provided the next cycle of EPOCH-R chemotherapy will not be delayed by \\> 7 days. In this situation, the date of receiving the first dose of EPOCH-R is considered C1D1 of the study treatment. Labs collected prior to C1D1, in accordance with SOC for the administration of these drugs, can be used for screening purposes\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including 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) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction in the last 6 months\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1.\n\n  * If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:\n\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  * Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled HIV\n\n  * Patients with known diagnosis of HIV must have undetectable viral load and be on anti-retroviral therapy\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Patients with known active central nervous system lymphoma\n* Patients needing a treatment regimen which would require use of mid-cycle high dose IV methotrexate for central nervous system (CNS) prophylaxis in the opinion of the treating provider\n* Pregnancy or lactation or intending to become pregnant during study",{"count":59,"type":20},18,[61],"PHASE2","This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab 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. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.",[64,27,65,66,67,68,69,70,71],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Transformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce","2026-04-21",{"date":74,"type":42},"2026-04-23",{"date":76,"type":42},"2025-12-07",{"date":78,"type":20},"2030-05-31",{"name":80,"class":49},"University of Washington",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100511054","phase-2-pembro-plus-car-t-cell-therapy-in-rr-in-pmbcl-100511054","NCT05934448","Pembro Plus CAR T-cell Therapy in R\u002FR in PMBCL","A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed\u002FRefractory Primary Mediastinal B-cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions.\n* Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be inadequate, tumor tissue must be obtained from a biopsy performed at screening, unless an exception is given after consultation with the sponsor-investigator.\n* Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial chemoimmunotherapy OR relapse within 12 months of front-line chemoimmunotherapy OR one prior line of therapy and not fit for HSCT.\n* ECOG Performance Status of 0 or 1.\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO).\n* Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator), defined as follows:\n\n  * ANC ≥ 1,000\u002FμL\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Platelet count ≥ 50,000\u002FμL\n* Participants must have adequate organ as defined below:\n\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver involvement)\n  * Adequate renal function defined by serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockcroft-Gault) ≥ 40 ml\u002Fmin for patients with serum creatinine \\>1.5 x ULN\n* At least one bi-dimensionally FDG-avid measurable lymphoma lesion on PET\u002FCT scan, defined as ≥ 1.5 cm in its longest dimension on CT scan, or ≥ 1 cm if extranodal (and measurable).\n* Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. This applies for the time period between signing of the informed consent form and 6 months for WOCBP and for men after the last administration of study treatment. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control, e.g. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, use of two forms of birth control, and sexual abstinence. The use of condoms by male patients is required unless the female partner is permanently sterile.\n* Age ≥18 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients in urgent need of cytoreductive therapy.\n* Participants who are receiving any other investigational agents.\n* History of other malignancies, except:\n\n  * Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before study registration\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Localized prostate cancer and low-risk prostate cancer on active surveillance\n  * In the opinion of the treating investigator, there is limited potential to interfere with the safety or efficacy of the investigational regimen. Such exceptions must be approved by the Sponsor-Investigator.\n* Has received a live vaccine within 30 days prior to study registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Less than 6 months of response to prior PD-L1 inhibitor or PD-1 inhibitor or grade 3 or higher immune-related adverse events.\n* Prior treatment with CAR T-cell therapy.\n* Lactating or pregnant. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) at screening. WOCBP will require a negative pregnancy test within 72 hours prior to starting treatment, but eligibility for study enrollment may be confirmed based on testing at screening.\n* Known active lymphomatous involvement of the central nervous system. History of prior CNS involvement is allowed.\n* Recent infection requiring intravenous antibiotics that was completed ≤7 days before the first dose of study drug, or any uncontrolled active systemic infection.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* History of Human immunodeficiency virus (HIV)-infection.\n* Has received prior radiotherapy within 2 weeks of study registration. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received prior systemic anti-cancer therapy within 2 weeks or investigational agents within 4 weeks.\n* Significant liver disease, such as hepatitis (viral or non-viral) or cirrhosis\n* Prior macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)\n* Uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of enrollment.\n* Known history of central nervous system or neurologic disease including stroke or intracranial hemorrhage within 3 months prior to enrollment or seizure disorder. Prior CNS involvement with lymphoma is allowed if previously treated with no evidence of involvement at study entry.\n* Prior solid organ or allogeneic stem cell transplant or within 6 weeks of autologous stem cell transplant.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Active pneumonitis or interstitial lung disease.\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has not met requirements for standard of care CAR-T therapy",{"count":89,"type":20},35,[61],"This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment.\n\nThe names of the study drugs involved in this study are:\n\n\\- Pembrolizumab\n\nStandard treatment will include:\n\n* CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel)\n* Cyclophosphamide\n* Fludarabine",[93,31,94,95,96,70],"Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Primary Mediastinal Large B-Cell Lymphoma Refractory","Primary Mediastinal Large B-Cell Lymphoma Recurrent","Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma",[93,31,94,95,70,98],"Epstein-Barr virus-positive diffuse large B-cell lymphoma","2026-03-03",{"date":101,"type":42},"2026-03-05",{"date":103,"type":42},"2023-11-15",{"date":105,"type":20},"2031-06-06",{"name":107,"class":49},"Jennifer Crombie, MD",2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":50},"100380306","phase-1-polatuzumab-vedotin-and-combination-chemotherapy-with-or-without-glofitamab-for-the-treatment-of-untreated-aggressive-large-b-cell-lymphoma-100380306","NCT04231877","Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma","A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin, With or Without Glofitamab, With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (PERCH) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive B-cell large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to rituximab-cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine (Oncovin), prednisone (R-CHOP) and in the opinion of the investigator would be treated with DA-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. Composite lymphomas are not excluded provided that the subject has not receive prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:\n\n  * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocations\n  * High grade B-cell lymphoma, not otherwise specified (NOS)\n  * Diffuse large B-cell lymphoma (DLBCL) NOS\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte-rich large-B-cell lymphoma\n  * Epstein-Barr virus (EBV) + DLBCL, NOS\n  * ALK+ large B-cell lymphoma (must be CD20+)\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n* Be willing and able to provide written informed consent for the trial\n* Be \\>= 18 years of age on day of signing informed consent\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on computed tomography (CT) or fluorodeoxyglucose-positron emission tomography (FDG-PET)\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)\n* Left ventricular ejection fraction (LVEF) \\>= 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002FuL except in cases of marrow infiltration by lymphoma\n* Platelets \\>= 75,000 \u002F mcL except in cases of marrow infiltration by lymphoma or hypersplenism\n* Hemoglobin \\>= 8 g\u002FdL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment\n* Measured or calculated creatinine clearance (Glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 40 mL\u002Fmin.\n\n  \\* Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin =\\\u003C 3.0 x ULN)\n* Direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) or Prothrombin Time (PT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, or subject is shown to have an antiphospholipid antibody on workup\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of =\\\u003C 1% per year during the treatment period and for at least 12 months after the last dose of EPCH-R, 9 months after the last dose of polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 3 months after the last dose of tocilizumab (if applicable), whichever is longer. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (=\\\u003C12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of =\\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. 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 post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of EPCH-R or polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 2 months after the last dose of tocilizumab (if applicable), whichever is longer. Men must refrain from donating sperm during this same period. 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 preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n* ARM B ONLY: Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products\n* Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.\n* Richter's transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion 1\n* Diagnosis of Burkitt lymphoma\n* Prior organ transplantation\n* Current Grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* Prior systemic therapy for indolent lymphoma\n* Prior use of any monoclonal antibody within 3 months of the start of cycle 1; any investigational therapy within 28 days prior to the start of cycle 1; vaccination with live vaccines within 28 days prior the start of cycle 1 and at any time during the study treatment period\n* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment) If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \\>= 2 years prior to enrollment are eligible\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including 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) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  \\* Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  \\* Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled human immunodeficiency virus (HIV)\n\n  \\* Patients with known diagnosis of HIV must have undetectable viral load, have a CD4 count ≥ 200\u002FμL, and be on anti-retroviral therapy. HIV positive patients should be monitored per local\u002Finstitutional standards while receiving study treatment\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or lactation or intending to become pregnant during study\n* ARM B ONLY: Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* ARM B ONLY: Known or suspected chronic active Epstein-Barr virus infection\n* ARM B ONLY: Current or past history of Waldenström macroglobulinemia\n* ARM B ONLY: Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, CNS lymphoma or neurodegenerative disease\n* ARM B ONLY: Active autoimmune disease which is not well controlled by therapy\n* ARM B ONLY: Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible\n* ARM B ONLY: Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n* ARM B ONLY: Participants with active autoimmune disease with dermatologic manifestations are eligible for the study\n* ARM B ONLY: Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded\n* ARM B ONLY: Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months\n* ARM B ONLY: Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis\n* ARM B ONLY: Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n* ARM B ONLY: Grade 3 infection within 4 weeks of treatment initiation",{"count":117,"type":20},56,[23],"This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.",[121,122,65,66,67,68,69,70,123],"Aggressive Non-Hodgkin Lymphoma","ALK-Positive Large B-Cell Lymphoma","Gray-Zone Lymphoma","2026-02-27",{"date":99,"type":42},{"date":127,"type":42},"2020-10-27",{"date":129,"type":20},"2031-12-01",{"name":80,"class":49},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":163,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":19},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":139,"type":20},98,[23],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[143,144,145,146,147,29,148,149,150,27,151,152,153,154,28,155,31,156,122,157,158,159,160,161,30,162],"Mature B-Cell Neoplasm","Non Hodgkin Lymphoma","DLBCL","Waldenstrom Macroglobulinemia","MALT Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Plasmablastic Lymphoma","High-grade B-cell Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","DLBCL Germinal Center B-Cell Type","T-Cell\u002FHistiocyte Rich Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Chronic Lymphocytic Leukemia","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Duodenal-Type Follicular Lymphoma",[164,165,146],"MALT1","NF-kB","2026-02-11",{"date":168,"type":42},"2026-02-13",{"date":170,"type":42},"2023-04-10",{"date":172,"type":20},"2027-11",{"name":174,"class":175},"Schrödinger, Inc.","INDUSTRY",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":108},"100558363","phase-2-emapalumab-prevention-of-car-t-cell-associated-toxicities-100558363","NCT06550141","Emapalumab Prevention of CAR-T Cell Associated Toxicities","A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities","Inclusion Criteria:\n\n* Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, 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* At least 1 measurable lesion per Lugano at time of screening.\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy however steroids only require a 7-day washout.\n* At least 3 half-lives must have elapsed from any prior systemic inhibitory\u002Fstimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc).\n* Age 18 or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n  * ANC ≥1000\u002FuL\n  * Platelet count ≥50,000\u002FuL\n  * Absolute lymphocyte count ≥100\u002FuL\n  * Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL\u002Fmin\n  * Serum ALT\u002FAST ≤2.5 per institutional ULN\n  * Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n  * Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings\n  * Baseline oxygen saturation \\>92% on room air.\n* 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).\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.\n* History of Richter's transformation of CLL.\n* Autologous stem cell transplant within 6 weeks of planned axicabtagene ciloleucel infusion.\n* History of allogeneic stem cell transplantation.\n* Presence of uncontrolled fungal, bacterial, viral, or other infection at time of screening.\n* Known history of 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 (IDSA) guidelines.\n\n  * Patients should also be negative for latent Tb, CMV (NAT), EBV (NAT) and adenovirus (NAT) by PCR testing.\n* No evidence of active CNS disease regardless of prior CNS history.\n* History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within 6 months of enrollment.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n* History of symptomatic pulmonary embolism within 3 months of enrollment; ongoing anticoagulation is allowed if beyond 3 months.\n* Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n* History of allergic reactions or severe immediate hypersensitivity reaction to any of the agents used in this study or compounds of similar chemical or biologic composition.\n* Females who are pregnant or breastfeeding or female or male participants who are not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel\n* In the investigators 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* History of autoimmune disease requiring ongoing systemic immunosuppression. Steroids are allowed up to 5mg predinosine-equivalent for adrenal insufficiency.\n* Patients anticipated to require canakinumab, JAK inhibitors, TNF inhibitors, and tocilizumab for non-CAR-T management of baseline autoimmune\u002Finflammatory disease at the time of emapalumab initiation.\n* Receipt of a BCG vaccine within 12 weeks prior to Screening.\n* Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screeing.\n* Participants who are receiving any other investigational agents for this condition.",{"count":184,"type":20},28,[61],"This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).\n\nThe research study involves the following study interventions:\n\n* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)\n* Axicabtagene Ciloleucel\n* Emapalumab",[188,189,26,32,190,152,29],"Large B-cell Lymphoma","Relapsed Non-Hodgkin Lymphoma","Primary Mediastinal Large B-cell Lymphoma",[192,193],"Second Line Large B-cell Non-Hodgkin's Lymphoma","Third Line Large B-cell Non-Hodgkin's Lymphoma","2025-11-12",{"date":196,"type":42},"2025-11-14",{"date":198,"type":42},"2024-09-18",{"date":200,"type":20},"2027-08-01",{"name":202,"class":49},"Marcela V. Maus, M.D.,Ph.D.",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":108},"100610273","phase-1-rituximab-rtx--tafasitamab-in-combination-with-allogeneic-nk-cells-for-treatment-of-relapsedrefractory-rr-b-cell-non-hodgkin-lymphoma-nhl-100610273","NCT07225439","Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma (NHL)","Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)\n* Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET\u002FCT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹\u002FL), lymphadenopathy ≥1.5 cm, and\u002For disease-related cytopenias (anemia, thrombocytopenia).\n* Relapsed and\u002For refractory after two or more lines of systemic therapy, including prior CD19 and\u002For CD20 directed therapies\n* For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and\u002For CD20 expression (by flow cytometry and\u002For immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy\n* ECOG Performance Status \\\u003C\u002F= 2\n* Preserved organ function as defined by: Total bilirubin \\\u003C\u002F= 1.5X upper limit of normal; AST\u002FALT \\\u003C\u002F= 2.5 X upper limit of normal; Calculated creatinine clearance \\>\u002F= 30mL\u002Fmin estimated by Cockcroft Gualt formula; cardiac ejection fraction \\>\u002F= 45% and no more than mild\u002Ftrace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \\>\u002F= 92% on room air.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator\n* Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment\n* New York Heart Association class III-IV congestive heart failure\n* Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration\n* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \\\u003C200 copies\u002FmL on antiretroviral therapy\n* Pregnant or breastfeeding women are excluded from this study because 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 NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Morphologic and\u002For cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy\n* Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)\n* Participants 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* Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases\u002FCNS 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 neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration\n* History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months",{"count":211,"type":20},15,[23],"This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.\n\nNK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).\n\nParticipants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.",[144,215,32,152,31,29,159,33,216,28],"B-cell Non Hodgkin Lymphoma","Marginal Zone Lymphoma",[218,219],"NK cells","Natural Killer cells","NOT_YET_RECRUITING","2025-11-04",{"date":223,"type":42},"2025-11-06",{"date":225,"type":20},"2025-12",{"date":227,"type":20},"2027-12",{"name":229,"class":49},"Paolo Caimi, MD",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":50},"100576351","vaccine-responses-in-patient-with-multiple-myeloma-and-non-hodgkin-lymphoma-after-car-t-treatment-100576351","NCT06784167","Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment","Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkins Lymphoma Post CAR-T Treatment","Inclusion Criteria:\n\n* \\* Willingness to provide written informed consent before any study-specific procedures or activities are performed\n\n  * Age ≥ 18 years of age, at the time of consent\n  * Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed\n  * History of prior vaccination against common VPD\n  * Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days\n  * Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus\n\nExclusion Criteria:\n\n* \\* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints\n\n  * Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or make the study procedures unadvisable",{"count":238,"type":20},45,"OBSERVATIONAL","This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.",[159,242,29,28,243,69,33],"Diffuse Large B-Cell Lymphoma","Multiple Myeloma","2025-09-08",{"date":246,"type":42},"2025-09-15",{"date":248,"type":42},"2025-03-10",{"date":250,"type":20},"2027-04-12",{"name":252,"class":49},"OHSU Knight Cancer Institute",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100468248","long-term-follow-up-study-of-lentiviral-based-gene-edited-immune-cell-therapy-100468248","NCT05377307","Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy","Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy","Inclusion Criteria:\n\n1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.\n2. The last lentiviral-based gene-edited immune cell infusion within 15 years.\n3. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for this study.",{"count":261,"type":20},49,"According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.",[32,188,31,264,265],"Follicular Lymphoma Grade 3A","Follicular Lymphoma Grade 3B",[267,268,269],"DLBCL(Diffuse Large B Cell Lymphoma)","PMLBCL(Primary Mediastinal Large B Cell Lymphoma)","FL(Follicular Lymphoma)","2025-05-07",{"date":272,"type":42},"2025-05-13",{"date":274,"type":42},"2022-12-29",{"date":276,"type":20},"2037-12",{"name":278,"class":175},"Pell Bio-Med Technology Co., Ltd.",5,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":279},"100464326","phase-1-phase-12-study-of-cd19-chimeric-antigen-receptor-t-cell-cd19-car-t-pl001-for-relapsed-or-refractory-b-cell-lymphoma-100464326","NCT05326243","Phase 1\u002F2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma","A Phase 1\u002F2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\nScreening 1:\n\n1. Patient is ≥14 years of age, inclusive, at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMLBCL), large B-cell lymphoma transformed from follicular lymphoma (FL), or grade 3a or 3b FL.\n3. On-site documentation of CD19 on the dominant population of cancer cells.\n4. Disease status should meet any one of the below:\n\n   1. Patients with previous autologous-hematopoietic stem cell transplantation (auto HSCT) have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after transplantation regardless of lines of systemic therapy.\n   2. Patients without previous HSCT have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after at least 2 lines of systemic therapy, including anti-CD20 antibody and anthracycline.\n5. Have no available effective systemic therapy as judged by the Investigator.\n6. At least one measurable non-CNS (central nervous system) lesion based on Lugano classification for lymphoma.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n8. Life expectancy of at least 3 months.\n9. Patient is male or female.\n10. A male patient must agree to use a highly effective contraception as detailed in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating sperm during this period.\n\n    Female Patients:\n11. A female patient is eligible to participate if she is not pregnant (Section 10.4; Appendix 4), not breastfeeding, and at least one of the following conditions applies:\n\n    • Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 (Appendix 4).\n\n    OR\n\n    • A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating ova during this period.\n12. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nScreening 2:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n2. CAR-T is successfully manufactured and ready for use, from cells harvested by non mobilized leukapheresis.\n3. WOCBP who have a negative serum pregnancy test at Screening 2.\n\nExclusion Criteria:\n\nScreening 1:\n\n1. Chronic lymphocytic leukemia with Richter's transformation.\n2. Primary CNS lymphoma. (Non-primary CNS lymphoma with CNS involvement is eligible).\n3. Primary intra-ocular lymphoma.\n4. Prior CD19 targeted therapy, such as CAR-T, Bi-specific T-cell engagers (BiTE), or monoclonal antibody.\n5. History of cancers (includes myelodysplastic syndrome) other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free without active treatment for at least 3 years.\n6. History of allogeneic HSCT.\n7. History of autologous HSCT within 3 months prior to consent.\n8. Received any investigational product within 4 weeks prior to consent.\n9. Systemic anticancer therapy within 3 weeks prior to apheresis.\n10. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent, within 2 weeks prior to leukapheresis.\n\n    Exception examples:\n    * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n    * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n    * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n11. Use of long-acting and short-acting myeloid growth factor within 2 weeks, 5 days prior to leukapheresis, respectively.\n12. Received anti-thymocyte globulin within 4 weeks prior to consent.\n13. Intrathecal chemotherapy within 1 week prior to leukapheresis.\n14. Inadequate major organ functions at Screening, which were defined as any of below:\n\n    1. absolute neutrophil count (ANC) \\\u003C500\u002FµL\n    2. Absolute lymphocyte count (ALC) \\\u003C300\u002FµL, excluding leukemic cells.\n    3. Hemoglobin (Hb) \\\u003C8.0 g\u002FdL\n    4. Platelet count \\\u003C75,000\u002FµL without transfusion support within 3 days\n    5. e. Baseline O2 saturation \\\u003C92% by pulse oximetry at room air\n    6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n    7. Aspartate aminotransferase (AST) \\>5 × upper limit of normal (ULN) and alanine aminotransferase (ALT) \\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n    8. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n    9. Significant cardiac disease including but not limited to: left ventricular ejection fraction (LVEF) \\\u003C50%, QTc(the corrected QT interval) \\> 480 msec based on Fredericia's formula, clinically significant arrhythmias, history of myocardial infarction or unstable angina within 3 months prior to consent.\n15. Active hepatitis B virus (HBV) infection defined as detectable HBV DNA (Patients with positive anti-hepatitis B core antibody \\[HBcAb\\] must consent to regular monitoring of HBV DNA, and anti-HBV prophylaxis with oral anti-viral agent (such as entecavir) is mandatory until End-of-Study visit \\[Visit 15\\].)\n16. Active hepatitis C virus (HCV) infection defined as positive anti- HCV antibody plus detectable HCV RNA.\n17. Positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) infection.\n18. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to apheresis).\n\n21\\. Any medical conditions which might compromise the patient's safety from leukapheresis, lymphodepletion chemotherapy, or CAR-T therapy and anticipated AEs, according to the Investigator's evaluation.\n\n22.Patients with insufficient leukapheresis cells.\n\nScreening 2:\n\n1. Inadequate major organ functions at Screening which were defined as any of below:\n\n   1. ANC \\\u003C500\u002FµL\n   2. Hb \\\u003C8.0 g\u002FdL\n   3. Platelet count \\\u003C50,000\u002FµL, without transfusion support within 3 days\n   4. Baseline O2 saturation \\\u003C92% by pulse oximetry on room air\n   5. AST \\>5 × ULN and ALT\\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n   6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n   7. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n2. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent.\n\n   Exception examples:\n   * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n   * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n   * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n3. Use of long-acting and short-acting myeloid growth factor within 12 days, 2 days prior to lymphodepletion therapy, respectively.\n4. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g. the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to lymphodepletion).\n5. Any medical condition which might compromise the patient's safety because of lymphodepletion chemotherapy or CAR-T therapy and anticipated AEs, according to the Investigator's opinion.","14 Years",{"count":261,"type":20},[23,61],"This is a multiple center, non-randomized, open-label, phase 1\u002F2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).",[32,31,188,264,265],[145,293,294],"PMLBCL","FL",{"date":272,"type":42},{"date":297,"type":42},"2022-05-31",{"date":299,"type":20},"2027-03-31",{"name":278,"class":175},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":308,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":312,"conditions":313,"keywords":317,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":108},"100577301","immunotherapy-in-lymphoma-100577301","NCT06796517","Immunotherapy in Lymphoma","Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed\u002FRefractory Lymphoma Patients","Inclusion Criteria:\n\n* Adults aged 19 to 74 years.\n* Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma\n* Patients who have received immunochemotherapy as treatment for relapsed\u002Frefractory lymphoma\n\nExclusion Criteria:\n\n* Patients who have progressed to acute leukemia\n* Patients who developed solid tumor during treatment\n* Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)","19 Years","74 Years",{"count":311,"type":20},72,"The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed\u002Frefractory high grade B cell lymophoma patients. The main question it aims to answer is:\n\nDoes advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?\n\nResearchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.\n\nLaboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.",[314,315,316,69,27],"Relapsed\u002Frefractory High Grade B Cell Lymphoma","High Grade B-cell Lymphoma","Diffuse Large B Cell Lymphoma Relapsed",[318,319,320,321],"immunochemotherapy","B cell lymphoma","Relapsed","Refractory","2025-01-27",{"date":324,"type":42},"2025-01-28",{"date":326,"type":42},"2024-06-26",{"date":328,"type":20},"2025-12-31",{"name":330,"class":49},"Sung-Soo Park",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":21,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100534424","phase-2-epcoritamab-compared-to-observation-for-treating-b-cell-lymphoma-patients-not-in-complete-remission-after-cd19-directed-car-t-therapy-100534424","NCT06238648","Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy","Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy","Inclusion Criteria:\n\n* Men and women \\>= 18 years of age\n* Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified \\[DLBCL NOS\\], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =\\\u003C 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry\n* Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at day 30 +\u002F- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)\n* Documented measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United \\[ACCRU\\] web site under Study Resources -\\> Forms)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\\\u003C 14 days prior to registration)\n* Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\>= 7.0 g\u002FdL if asymptomatic or hemoglobin \\> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: symptoms include shortness of breath, fatigue, lightheadedness\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is =\\\u003C 5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance must be \\>= 45 mL\u002Fmin using the Crockcroft- Gault formula (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms.\"\n* Negative serum pregnancy test done =\\\u003C 7 days prior to registration for a woman of childbearing potential (WOCBP) only\n\n  * NOTE: A WOCBP is a sexually mature female who:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Provide informed written consent =\\\u003C 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment and clinical follow-up)\n* Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes\n\nExclusion Criteria:\n\n* Patients post CAR-T who have bulky disease defined as a disease focus \\>= 7.5cm in diameter at day 30 +\u002F- 7 days PET-CT assessment\n* Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +\u002F- 7 days PET-CT assessment based on Lugano criteria\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)\n* Any of the following prior therapies:\n\n  * CD20xCD3 bispecific antibody at any point prior to registration\n  * CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) =\\\u003C 4 weeks prior to registration\n* Ongoing cytokine release syndrome (CRS) or neurotoxicity post CAR-T\n* Prior grade 4 CRS or neurotoxicity after most recently administered CAR-T\n* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening and based on clinical symptoms, MRI, or lumbar puncture\n* Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\\\u003C 14 days prior to registration, including COVID- 19 infection.\n\n    * NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and on suppressive therapy.\n    * NOTE: If history of treated hepatitis C virus (HCV) infection, HCV viral load must be undetectable.\n    * NOTE: Patients known to be human immunodeficiency virus (HIV) positive, but stable on anti-retroviral therapy with an undetectable HIV viral load pre-CART, are eligible for this trial.\n    * NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment\n    * NOTE: Past COVID-19 infection may be a risk factor, but if resolved symptoms and the subject is vaccinated, they may be enrolled\n  * Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class 3 or 4)\n  * Unstable angina pectoris\n  * Unstable cardiac arrhythmia present =\\\u003C 14 days prior to registration\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement\n  * History or presence of CNS disorder such as seizure disorder (not including resolved childhood febrile seizures), cerebrovascular ischemia\u002Fhemorrhage (not including transient ischemic attacks), cerebellar disease, or any autoimmune disease with CNS involvement\n* Receiving any other investigational agent which would be considered treatment for the primary neoplasm =\\\u003C 14 days prior to registration\n* Other active malignancy requiring therapy \\\u003C 2 years prior to registration (localized non-melanoma skin cancer is allowed)\n* Clinically significant cardiovascular disease, including: Myocardial infarction within 1 year prior to randomization, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV) cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities",{"count":339,"type":20},120,[61],"This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.",[65,69,343],"Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2024-09-24",{"date":346,"type":42},"2024-09-26",{"date":348,"type":42},"2024-01-31",{"date":350,"type":20},"2030-12-31",{"name":352,"class":49},"Academic and Community Cancer Research United",6,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":108},"100425820","circulating-tumor-dna-in-primary-mediastinal-large-b-cell-lymphoma-pmbl-100425820","NCT04824950","Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)","CAMIL","Inclusion Criteria:\n\n* Patient over 18 years of age,\n* Suffering from a diffuse primary B lymphoma of the mediastinum, newly diagnosed locally on a biopsy with anatomopathological analysis according to the recommendations of the WHO 2016 classification of hematological malignancies,\n* All stages (I-IV)\n* All IPI scores (0-5)\n* With mediastinal involvement,\n* Untreated (apart from emergency corticosteroid therapy less than 2mg\u002Fkg\u002Fday for 7 days),\n* Treatment with R-CHOP-14 or R-ACVBP with PET-CT guided strategy (delta SUVmax) to be initiated,\n* Tumor fixation above liver background on pre-treatment FDG PET\u002FCT\u002FCT (Deauville score ≥4),\n* Having signed the informed consent prior to any study procedure\n* Affiliated or beneficiary of a social protection plan.\n\nExclusion Criteria:\n\n* Patient who has already started chemotherapy treatment,\n* Contraindication to FDG PET-CT,\n* No mediastinal involvement,\n* Positive HIV serology,\n* Positive hepatitis B or C serology with positive viral load,\n* Protected adult (under guardianship or curatorship),\n* Pregnant or breastfeeding women,\n* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).",{"count":362,"type":20},87,[364],"NA","The purpose of this study is to compare the predictive value in terms of specificity of circulating tumor DNA (ctDNA) and positron emission computed tomography (PET-CT) after 2 cycles of chemotherapy (C2), on the probability of obtaining a metabolic complete response after 4 cycles of induction chemotherapy (C4) in patients with primary mediastinal large B cell lymphoma (PMBL) receiving standard R-CHOP14 or R-ACVBP.",[190],[190,368,369],"Circulating tumor DNA","Next Generation sequencing","2021-03-29",{"date":372,"type":42},"2021-04-01",{"date":374,"type":20},"2021-03-22",{"date":376,"type":20},"2028-03-01",{"name":378,"class":49},"Centre Henri Becquerel"]