[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-large-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,82],{"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":25,"conditions":26,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100426707","phase-1-study-of-efficacy-and-safety-of-crc01-in-adult-large-b-cell-lymphoma-and-b-cell-acute-lymphoblastic-leukemia-patients-100426707",false,"NCT04836507","Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia","Cohort A:\n\nInclusion Criteria:\n\n1. ≥ 19 years of age and provided written informed consent\n2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017\n\n   * Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma)\n   * High-grade B-cell lymphoma, not otherwise specified\n   * High-grade B-cell lymphoma with double-hit\u002Ftriple-hit\n   * Primary mediastinal large B cell lymphoma\n3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.\n4. At least one measurable lesion (Long diameter ≥ 1.5cm)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate renal and hepatic functions based on the laboratory test results\n\n   * Total Bilirubin ≤ 2.0mg\u002FdL with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN.\n   * Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X Upper Limit of Normal (ULN) for age with exception of liver metastasis; patients with liver metastasis may be included if their AST and ALT are ≤ 5 X ULN.\n   * Serum creatinine ≤ 1.5 X ULN\n   * Estimated Glomerular Filtration Rate (eGFR) ≥ 60mL\u002Fmin\u002F1.73m2\n7. Adequate hematologic function without transfusions within 2 weeks prior to screening for the study defined as followings:\n\n   * Hemoglobin \\> 8.0g\u002F㎗\n   * Absolute Neutrophil Count (ANC) \\> 1,000\u002F㎕\n   * Absolute Lymphocyte Count (ALC) ≥ 300\u002F㎕\n   * Platelets ≥ 50,000\u002F㎕\n8. Must have a minimum level of pulmonary reserve defined as;\n\n   * ≤ Grade 1 dyspnea per Common terminology criteria for adverse events (CTCAE) v5.0\n   * pulse oxygenation \\> 91% on room air\n9. Hemodynamically stable, without pericardial effusion and Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA)\n10. Must have an apheresis product of non-mobilized cells accepted for manufacturing\n11. Life expectancy ≥ 12 weeks\n12. Women of child-bearing potential and all male participants must agree to use highly effective methods of contraception for at least 12 months following CRC01 infusion and until CRC01 are no longer present by PCR on two consecutive tests\n\nExclusion Criteria:\n\n1. Patients with the following medical history\n\n   * Previous or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n   * Unstable angina and\u002For myocardial infarction within 12 months prior to screening\n   * Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to screening\n   * Hypoxemia, significant pleural effusion or significant EKG findings within 6 months prior to the screening\n2. Patients with the following concurrent disease at screening:\n\n   * Central Nervous System (CNS) involvement by malignancy by MRI at screening\n   * Active infection with hepatitis B (HBsAg positive. But, in case of HBcAb IgG positive, the patient can be enrolled in this study if he\u002Fshe takes prophylactic anti-viral agent.)\n   * Active infection with hepatitis C (HCV RNA positive)\n   * Human immunodeficiency virus (HIV) positive\n   * Active neurological auto-immune or inflammatory disorder (e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis)\n   * Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled with medical treatment within 3 months prior to screening\n3. Rapidly progressing the disease as per investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within 4 weeks prior to screening (For video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery can be applied with within 2 weeks prior to screening.)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection\n6. The following treatment history is excluded:\n\n   * Prior treatment with any prior anti-CD19\u002Fanti-CD3 therapy or any other anti-CD19 therapy\n   * Prior treatment with any adoptive T cell therapy\n   * Treatment with any prior gene therapy product\n   * Prior allogeneic HSCT\n   * Patients on oral anticoagulation therapy\n7. Eligible for and consenting to ASCT\n8. Use of investigational medicinal product\u002Fdevice within 4 weeks prior to screening\n9. Pregnant or lactating women\n10. Hypersensitivity reaction to the excipients of CRC01 cell product\n11. The following treatments are excluded:\n\n    * Anti-neoplastic therapies including chemotherapy, biologic agents, retinoid therapy, radiotherapy, immune therapy, hormonal therapy, etc. other than lymphodepleting chemotherapy within 2 weeks of leukapheresis and within 2 weeks of CRC01 infusion\n    * Steroids: therapeutic doses of steroids must be stopped \\> 7 days prior to leukapheresis and \\> 5 days prior to CRC01 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 6 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n    * Immunosuppression: any immunosuppressive medication must be stopped \\> 4 weeks prior to leukapheresis and \\> 4 weeks prior to CRC01 infusion\n    * Antibody use including anti-CD20 therapy within 4 weeks prior to CRC01 infusion\n    * CNS disease prophylaxis must be stopped \\> 1 week prior to CRC01 infusion (e.g. intrathecal methotrexate)\n\nCohort B :\n\nInclusion Criteria :\n\n1. ≥ 19 years of age and provided written informed consent to voluntarily participate in this trial\n2. Relapsed or refractory B-cell lymphoblastic leukemia with one of the following:\n\n   * Primary refractory: Newly diagnosed and refractory to 2 or more cycles of standard chemotherapy\n   * Relapsed within 12 months of the first complete remission\n   * Chemorefractory: Refractory to 1 cycle of chemotherapy conducted after relapse\n   * Relapsed after or refractory to two or more lines of chemotherapy\n   * Relapsed or refractory 100 days after allogeneic HSCT\n3. (within 4 weeks prior to screening) Blast of \\> 5% identified in the BM\n4. (within 4 weeks prior to screening) BM or peripheral blood blast confirmed CD19-positive.\n\n   Specifically, those with prior treatment with any other anti-CD19 therapy must be confirmed to show CD19 ≥ 90%.\n5. Philadelphia chromosome positive with one of the following:\n\n   * Unable to take tyrosine kinase inhibitors (TKIs) due to side effects\n   * Relapsed or refractory despite treatment with two or more TKIs\n6. ECOG performance status of 0-1\n7. Confirmed adequate hematologic function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 500\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Platelet count ≥ 50,000\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Absolute lymphocyte count ≥ 200\u002FμL\n8. Adequate renal and hepatic functions confirmed based on the laboratory test results:\n\n   * Total Bilirubin ≤ 2.0 mg\u002FdL (for patients with Gilbert-Meulengracht syndrome, total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN)\n   * AST and ALT ≤ 3 × ULN\n   * Serum creatinine ≤ 1.5 × ULN or eGFR\\* ≥ 45 mL\u002Fmin\u002F1.73 m2 \\*MDRD-GFR (mL\u002Fmin\u002F1.73 m2) = 186 × (serum creatinine)-1.154 × (age)-0.203 (× 0.742 for females)\n9. Confirmed to have a minimum level of pulmonary reserve according to the following criteria:\n\n   * ≤ Grade 1 dyspnea per CTCAE v5.0\n   * Pulse oxygenation \\> 91% on room air\n10. Hemodynamically stable, without pericardial effusion, and LVEF ≥ 50% confirmed by ECHO or MUGA scan at Screening\n11. Capable of obtaining through leukapheresis non-mobilized cells adequate for CRC01 manufacturing\n12. Life expectancy of ≥ 12 weeks\n13. Consented to comply with the site visit and test schedules for Primary Follow-up and Secondary Follow-up in accordance with the Protocol for the duration of the Study\n14. WOCBP or male subjects who are willing to use appropriate contraceptive methods\\* for at least 12 months following CRC01 treatment and until CRC01 is no longer detected through two consecutive PCR tests \\* Hormonal contraceptives, placement of intrauterine system, double barrier method (simultaneous use of contraceptive vaginal diaphragm or cervical cap and male condom, along with spermicide), sterilization (vasectomy, bilateral tubal ligation), etc.\n\nExclusion Criteria:\n\nPatients in Cohort B may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medication or treatment history:\n\n   ① Donor lymphocyte infusion (DLI) within 4 weeks\n   * Graft-versus-host-disease (GVHD) treatment within four weeks (In case of maintaining medication for post-treatment prophylaxis, the decision on the subject's participation in the clinical trial may be made after contacting and consulting with the Sponsor's Medical Monitor.)\n\n     * Central nervous system (CNS) radiotherapy or intracerebrospinal antineoplastic therapy within eight weeks (However, intrathecal therapy for prophylaxis purposes is an exception) ④ Systemic salvage chemotherapy that includes TKI and blinatumomab for treatment of Philadelphia positive ALL within one week prior to Screening or five half-lives of the administered drug (whichever is shorter)\n\n       * Any prior anti-CD19 treatment (with the exception of blinatumomab) ⑥ History of neurological toxicity ≥ Grade 4 or cytokine release syndrome (CRS) ≥ Grade 4 per CTCAE during prior anti-CD19 treatment\n2. Patients with the following CNS abnormality:\n\n   ① CNS-3 disease, defined by WBC ≥ 5\u002FμL in CSF and confirmed presence of lymphoblast, with or without neurological symptoms\n\n   ② CNS-3 disease, defined by WBC \\\u003C 5\u002FμL in CSF and confirmed presence of lymphoblast, with neurological symptoms (cases of CNS-1 disease without evidence of leukemia involvement in CSF and CNS-2 disease without neurological symptoms may be enrolled)\n\n   ③ Current or prior history of CNS disorder, such as epilepsy\u002Fseizure, cerebrovascular ischemia\u002Fbleeding, dementia, cerebellar disorder, autoimmune disease with CNS invasion, posterior reversible encephalopathy syndrome (PRES) or cerebral edema\n3. Burkitt's lymphoma\u002Fleukemia per WHO Classification or chronic myelogenous leukemia lymphoid blast crisis\n4. Primary immunodeficiency\n5. Hereditary diseases (e.g., Fanconi anemia, Kostmann syndrome, and Shwachman-Diamond syndrome) or other bone marrow failure syndromes\n\n2\\. Common Exclusion Criteria\n\nSubjects in Phase 1 study and Phase 2 study may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medical history:\n\n   * History of malignancy with the following exceptions:\n\n     • Basal cell or squamous cell skin cancer treated without relapse for at least three years prior to Screening\n\n     • In-situ carcinoma of the cervix or breast treated without relapse for at least 3 years prior to Screening\n     * Superficial bladder cancer treated without relapse for at least 3 years prior to Screening\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n\n       * Unstable angina and\u002For myocardial infarction within 12 months prior to Screening ③ Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to Screening\n\n         * Hypoxemia, clinically significant pleural effusion or clinically significant ECG findings within 6 months prior to Screening\n2. Patients with the following concurrent disease at Screening:\n\n   * Central nervous system (CNS) involvement by malignancy by magnetic resonance imaging (MRI) at Screening. However, for Cohort B, subjects with malignant tumor metastasis to the brain parenchyma confirmed by MRI scan.\n\n     * Active infection with hepatitis B confirmed (HBsAg positive at Screening. But, in case of HBcAb IgG positive, the patient can be enrolled if he\u002Fshe takes prophylactic anti-viral agent.)\n\n       * Active infection with hepatitis C confirmed (HCV Ab tested positive at Screening. But, if screened negative for HCV RNA, the patient can be enrolled.) ④ Known human immunodeficiency virus (HIV) positive ⑤ Active neurological auto-immune or inflammatory disorder (e.g., Guillain Barre syndrome, amyotrophic lateral sclerosis) ⑥ Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled (i.e., relapsed or symptomatic) with pharmacological treatment within three months prior to Screening\n3. Showing rapid progression of study disease as per Investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within four weeks prior to Screening (for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery, within two weeks prior to Screening)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection at Screening\n6. Use of other investigational medicinal products\u002Fdevices within 4 weeks prior to Screening\n7. Pregnant or lactating women\n8. Hypersensitivity reaction to the ingredients of the Investigational Product\n\nOther protocol-related inclusion\u002Fexclusion may apply.","ALL","19 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multi-center, phase I\u002FII study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.",[27,28,29,30,31,32,33],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Diffuse Large B-cell Lymphoma (DLBCL)","Primary Mediastinal Large B-Cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Transformed Follicular Lymphoma (TFL)","ALL (Acute B-Lymphoblastic Leukemia)",[35,36,37,38,39,40,41],"CRC01","anti-CD19 CAR-T","CAR-T","CAR T cells","Chimeric antigen receptor","PD-1 knock down","TIGIT knock down","RECRUITING","2026-06-29",{"date":45,"type":46},"2026-07-01","ACTUAL",{"date":48,"type":46},"2021-03-02",{"date":50,"type":20},"2030-09-26",{"name":52,"class":53},"Curocell Inc.","INDUSTRY",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100629322","phase-1-study-of-safety-and-efficacy-of-tc011-in-the-relapsedrefractory-large-b-cell-non-hodgkin-lymphoma-patients-100629322","NCT07473167","Study of Safety and Efficacy of TC011 in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","A Multi-center, Single Arm, Open-label Phase 1\u002F2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","TC011","Inclusion Criteria:\n\nSubjects must meet all criteria including:\n\n* ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks\n* Histologically confirmed B-cell lymphoma (WHO 2017)\n* Relapsed\u002Frefractory after ≥2 prior lines of systemic chemotherapy\n* ≥1 measurable lesion (longest diameter ≥1.5 cm)\n* Adequate organ, and pulmonary function\n* LVEF ≥40%\n* Able to undergo leukapheresis\n* For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion\n\nExclusion Criteria:\n\n* Unresolved ≥Grade 2 toxicities from prior therapy\n* Malignancy within 2 years except specified exceptions\n* Significant cardiac disease within 6 months\n* CNS involvement by lymphoma\n* Active HBV, HCV, HIV, syphilis\n* Rapidly progressing disease per investigator\n* Major surgery requiring general anesthesia within 4 weeks\n* Active or uncontrolled infection\n* Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT\n* Use of other investigational agents, immunosuppressants within protocol-specified windows\n* Pregnancy or breastfeeding\n* Hypersensitivity to study drug components\n* Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)",{"count":64,"type":20},98,[23,24],"This is a multi-center, phase I\u002FII study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.",[27,28,29,68,32,69],"High-grade B-cell Lymphoma (HGBL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[61,37,39,71],"CLIP","2026-03-10",{"date":74,"type":46},"2026-03-16",{"date":76,"type":46},"2023-08-03",{"date":78,"type":20},"2028-03-10",{"name":80,"class":53},"TICAROS Co., Ltd.",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":54},"100578436","phase-2-outpatient-epcoritamab-as-2l-in-nte-rr-dlbcl-100578436","NCT06811272","Outpatient Epcoritamab as 2L in NTE R\u002FR DLBCL","A Phase 2 Study of Outpatient Epcoritamab as Second Line Therapy in Non-Transplant Eligible Relapsed\u002FRefractory Large B-cell Lymphoma","Inclusion Criteria:\n\n* Participants must have large B-cell lymphoma of one of the following histologic subtypes by WHO criteria:\n\n  * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)\n  * High grade B-cell lymphoma (HGBCL) with rearrangements of MYC and BCL2 and\u002For BCL6\n  * HGBCL NOS\n  * EBV+ DLBCL\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte rich LBCL\n  * Grade 3B follicular lymphoma\n  * Large B-cell lymphoma transformed from underlying indolent NHL\n* PET measurable disease per Lugano criteria.\n* Relapsed or refractory disease treated with 1 prior systemic antineoplastic line of therapy that includes an anti-CD20 monoclonal antibody and an anthracycline or an alkylating agent. Patients who have received more than 1 prior systemic antineoplastic line of therapy are not eligible.\n* Age ≥18 years.\n* ECOG performance status 0-2.\n* Not a candidate for high dose chemotherapy and autologous stem cell transplant per the treating investigator, or patient refusal of high dose chemotherapy and autologous transplant.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1,000\u002FmcL (Growth factor support is permitted)\n  * platelets ≥75,000\u002FmcL (\\>50,000 in the presence of bone marrow involvement or splenomegaly; platelet transfusions are permitted)\n  * Hemoglobin ≥8 g\u002FdL (\\>7 g\u002FdL in the presence of bone marrow involvement; blood transfusions are permitted)\n* Participants must have adequate organ function as defined below (unless abnormalities are considered related to target organ involvement or compression by lymphoma):\n\n  * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) (Isolated bilirubin ≤3.0x ULN is acceptable if considered secondary to Gilbert's syndrome)\n  * AST(SGOT) and ALT(SGPT) ≤3.0x institutional ULN\n  * Creatinine clearance ≥45 mL\u002Fmin eGFR (Cockcroft-Gault or MDRD equation)\n  * PT within institutional normal range (unless on anticoagulation expected to affect PT, in which case PT cut off does not apply)\n  * PTT within institutional normal range (unless on anticoagulation expected to affect PTT, in which case PTT cut off does not apply)\n* Ability to remain within 60 minutes of the administration site for 24 hours following cycle 1 day 15 dose of study drug.\n* The effects of epcoritamab on the developing human fetus are unknown. Women of child-bearing potential must agree to use adequate contraception starting with the first dose of study drug, for the duration of study participation, and for at least 6 months after the last dose of study intervention. Women must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Adequate contraception methods:\n\n  * Male Partner Sterilization: When the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate.\n  * Use of a combination of any two of the following (one from \"a\" and one from \"b\"):\n\n    1. Placement of an intrauterine device (IUD) or intrauterine system or established use of oral, injected, or implanted hormonal methods of contraception\n    2. Barrier methods of contraception: Male Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n* True abstinence, defined as refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject.\n* Nonchildbearing potential is defined as follows:\n\n  * ≥45 years of age and has not had menses for at least 12 consecutive months.\n  * Subjects who have been amenorrhoeic for \\\u003C1 year must have, on at least two occasions prior to first dose of study drug, a follicle stimulating hormone value greater than 40 IU\u002FL; historical follicle stimulating hormone values are eligible\n  * Post-bilateral oophorectomy (with or without hysterectomy) or post-tubal ligation at least six weeks prior to first dose of study drug. Documented oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. In the case of oophorectomy alone, reproductive status must be confirmed by follicle stimulating hormone level assessment as above.\n* Women of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at screening.\n* Fertile men, defined as all males physiologically capable of conceiving offspring who are sexually active with a female partner of childbearing potential, must agree to use adequate contraception starting with the first dose of study drug, for the duration of study participation, and 3 months after completion of administration. Men must also agree not to donate sperm during this period. Men may agree to remain abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term or persistent basis) OR agree to use a male condom, and their female partner must use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year when having sexual intercourse if they are a WOCBP (including pregnant females).\n* Ability to understand and the willingness to sign a written informed consent document by the participant or a legally authorized representative.\n\nExclusion Criteria:\n\n* Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped at least 7 days prior to the first dose of study drug.\n* Participants must not have received prior CD20\u002FCD3 bispecific antibody.\n* Participants must not have received prior autologous or allogeneic stem cell transplant.\n* Participants must not have received prior anti-CD19 CAR T-cell therapy.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia. At the discretion of the overall PI, participants with residual toxicities \\> Grade 1 may be considered eligible if in the opinion of the overall PI the residual toxicity is not likely to interfere with the safety or efficacy assessment of the investigational regimen. For residual hematologic toxicities greater than Grade 1.\n* Participants must not have known central nervous system involvement by lymphoma.\n* Participants must not have a current life-threatening illness, medical condition, or organ system dysfunction (other than the disease under study) which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk. Patients that have mild cognitive impairment or dementia are eligible per investigators' opinion.\n* Participants must not have an uncontrolled active infection. Localized fungal infection of skin or nails are permitted.\n* Participants must not have active uncontrolled autoimmune disease. Autoimmune disease under control with chronic systemic corticosteroids at a dose of 10 mg\u002Fday of prednisone or less, or equivalent corticosteroid, are eligible.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab. A history of an infusion reaction to CD20-directed therapy is not considered an allergic reaction.\n* Women who are pregnant are excluded from this study because it is unknown if epcoritamab can cause embryo-fetal harm when administered to a pregnant woman. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with epcoritamab, breastfeeding should be discontinued if the mother is treated with epcoritamab on study.\n* Participant must not have active uncontrolled HIV infection. Participants with HIV are eligible if disease is adequately controlled on an antiretroviral regimen that is in accordance with the current international AIDS Society guidelines, with adequate control defined by presence of both an undetectable viral load, a CD4 count \\>350, no evidence of AIDS-defining illness (with the exception of a lymphoma diagnosis), and no active opportunistic infections (infections controlled on appropriate anti-infective therapy are permitted).\n* Participant must not have active hepatitis B infection. Participants with positive HBV core antibody or HBV surface antigen at screening are eligible if HBV viral load is negative by PCR and they are on appropriate antiviral therapy.\n* Participant must not have active hepatitis C infection. Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Note: Participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.\n* Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or has had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria: No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection AND negative testing (molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours).\n* Participants must not have received a live virus vaccine within 28 days of first dose of study drug.\n* Participants must not have any known past or current malignancy other than inclusion diagnosis, except for:\n\n  1. Cervical carcinoma of Stage 1B or less.\n  2. Non-invasive basal cell or squamous cell skin carcinoma.\n  3. Non-invasive, superficial bladder cancer.\n  4. Prostate cancer with a current PSA level \\\u003C0.1 ng\u002FmL.\n  5. Any curable cancer with a complete response (CR) of \\>2 years duration","18 Years",{"count":91,"type":20},30,[24],"The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed\u002Frefractory large B-cell lymphoma.",[27,28],[96,97,98,99],"Non-Transplant Eligible","Second Line Therapy","DLBCL","HGBCL","2026-02-22",{"date":102,"type":46},"2026-02-24",{"date":104,"type":46},"2025-06-05",{"date":106,"type":20},"2028-10-01",{"name":108,"class":109},"Massachusetts General Hospital","OTHER"]