[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dlbcl-nos-genetic-subtypes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dlbcl-nos-genetic-subtypes":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":52},"100401858","early-phase-1-iomab-act-a-pilot-study-of-131-i-apamistamab-followed-by-cd19-targeted-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-or-diffuse-large-b-cell-lymphoma-100401858",false,"NCT04512716","Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma","Patients with B-ALL or DLBCL (or subtypes thereof) who have relapsed or refractory disease will be eligible. Refractory disease is defined by failure to achieve at least a partial response or disease progression within 6 months of the last therapy. Patients who initially respond but subsequently demonstrate disease progression are considered to have relapsed disease\n\nParticipant Inclusion Criteria:\n\n\\- To be eligible for leukapheresis, patients must have a CD19+ B-cell malignancy with relapsed or refractory disease, defined below. To be eligible for 131-I apamistamab conditioning and treatment with 19-28z CAR T-cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR T-cell infusion (as defined below), regardless of therapy administered following leukapheresis.\n\na. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \\[Richter syndrome\\]) or high-grade B-cell lymphoma (HGBL): (\"DLBCL patients\") i. Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following 2 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL\u002FHGBL or DLBCL arising from indolent lymphoma, and requiring further treatment. Exception: patients with Richter syndrome (DLBCL arising from CLL\u002Fsmall lymphocytic lymphoma) are eligible following 1 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) and do not require a second course of chemoimmunotherapy to be eligible.\n\nii. Patients must have at least one FDG-avid (PET-avid) measurable lesion iii. Biopsy confirmation of relapsed of refractory DLBCL is required iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria a.i.-a.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\nb. Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: (\"B-ALL patients\") i. Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy ii. Patients with Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor iii. Patients must have ≥5% bone marrow involvement and\u002For at least one FDG-avid (PET-avid) measurable extramedullary lesion iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria b.i.-b.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\n* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.\n* Age ≥ 18 years of age\n* Creatinine clearance ≥50 mL\u002Fmin as calculated by the Cockroft-Gault formula\n* Direct bilirubin ≤2.0 mg\u002FdL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy\n* Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.\n* Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:\n\n  1. Absolute neutrophil count ≥0.5k\u002FµL,\n  2. Platelets ≥30k\u002FµL,\n  3. Hemoglobin ≥7g\u002FdL.\n* ECOG performance status 0-2.\n\nParticipant Exclusion Criteria:\n\n* ECOG performance status ≥3.\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by echocardiogram or MUGA scan during screening\n* Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible\n* Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible\n* Patients with following cardiac conditions will be excluded:\n\n  1. New York Heart Association (NYHA) stage III or IV congestive heart failure\n  2. Myocardial infarction ≤6 months prior to enrollment\n  3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n  4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%\n* Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:\n\n  1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.\n  2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.\n* Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)\n\nSubject Inclusion Criteria for 131-I Apamistamab Infusion Patients should meet performance status and organ function parameters as specified, without known development of an exclusion criterion, prior to proceeding to 131-I apamistamab infusion. See Section 9.2 re: screening for treatment.","ALL","18 Years",{"count":18,"type":19},12,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.",[25,26,27,28,29,30,31,32,33,34,35],"B-ALL","DLBCL","B ALL","Dlbcl-Ci","DLBCL Unclassifiable","DLBCL, Nos Genetic Subtypes","DLBCL Activated B-Cell Type","DLBCL Germinal Center B-Cell Type","Diffuse Large B-cell Lymphoma","HGBL","HGBL, Nos",[37,38,39,40],"CD19+ B-cell malignancy","131-I apamistamab","B-cell malignancy","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-02-13",{"date":44,"type":45},"2026-02-17","ACTUAL",{"date":47,"type":45},"2021-02-02",{"date":49,"type":19},"2027-01",{"name":40,"class":51},"OTHER",7,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":20,"phases":64,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100579879","phase-1-clinical-study-of-c402-cd19-car-treatment-in-subjects-with-relapsed-or-refractory-b-cell-lymphoma-100579879","NCT06830031","Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma","A Phase 1 Study of C402-CD19-CAR, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Targeting CD19 in Subjects With Relapsed or Refractory Large B-cell Lymphoma","C402","Inclusion Criteria:\n\nMust meet all the following inclusion criteria:\n\n1. Male or female 18-75 years (inclusive);\n2. Patients can understand this study and capable of providing informed consent;\n3. Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements;\n4. Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), grade 3b follicular lymphoma (FL), transformed diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBL), high-grade B-cell lymphoma (HGBL) with MYC, BCL-2, and\u002For BCL-6 rearrangements, and high-grade B-cell lymphoma not otherwise specified (HGBL-NOS). For CD19 expression status, subjects with a clear past record of tumor histological diagnosis as CD19-positive (within 6 months prior to screening with no CD19-related treatment in the last 6 months) and tumors showing CD19-positive lymphoma levels ≥ 50% by IHC or CD19-positive lymphoma levels ≥ 70% by flow cytometry. If there is no previous CD19 tumor testing or the result is over 6 months prior to screening, a new tumor pathology sample must be provided or re-collected for CD19-positive diagnosis by the institution, with IHC showing CD19-positive lymphoma levels ≥ 50% or flow cytometry showing CD19-positive lymphoma levels ≥ 70%.\n5. For refractory or relapsed large B-cell lymphoma subjects, must have received at least anthracycline-based therapy and rituximab (or other CD20-targeted drugs, excluding CD20-negative cases). If previously treated with R-CHOP or other CD20-targeted therapy, the best treatment outcome prior to relapse must have been complete remission (CR). Subjects should meet the criteria for relapse, progression, or failure after second-line therapy; or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT). If the subject has undergone previous auto-HSCT, the best treatment outcome prior to relapse must have been CR, and the relapse should occur more than 12 months after the previous treatment. (Refractory is defined as the best response to the most recent treatment being disease progression or stable disease after at least 2 cycles of the last-line therapy).\n6. According to the 2014 Lugano Treatment Response Assessment Criteria, at least one measurable tumor lesion should be present (lesions can be measured with PET results; lymph node lesions \\[long axis LDi \\> 15mm\\] or extra nodal lesions \\[long axis LDi \\> 10mm\\]);\n7. Expected survival time greater than 12 weeks;\n8. ECOG score of 0-1;\n9. Able to establish an intravenous route for PBMC collection, meeting the following hematologic parameters before screening: Hemoglobin ≥ 80 g\u002FL, absolute neutrophil count ≥ 1.0 × 10\\^9\u002FL, platelet count ≥ 75 × 10\\^9\u002FL, lymphocyte count ≥ 0.5 × 10\\^9\u002FL (if using bone marrow stimulants or blood transfusion, a washout period of 7 days is required; for granulocyte colony-stimulating factor \\[G-CSF\\] or granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], a washout period of 4 weeks or 5 half-lives is required);\n10. Liver and kidney function, as well as heart and lung function, should meet the following requirements:\n\n    1. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula);\n    2. Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected;\n    3. Oxygen saturation ≥ 92% without oxygen support;\n    4. Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN);\n    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;\n    6. Fibrinogen ≥ 1.0 g\u002FL; activated partial thromboplastin time ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;\n11. No more than 1 month prior to screening, the subject must have participated in another interventional clinical study and recovered to a severity level of ≤ 1 for any treatment-related adverse events.\n\nExclusion Criteria:\n\n1. History of receiving allogeneic hematopoietic stem cell transplantation, adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell therapies;\n2. Any active central nervous system (CNS) involvement (including symptomatic and asymptomatic), or a history of CNS disease (such as epilepsy, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the CNS);\n3. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA positivity, or subjects with HBV titers above the upper limit of the normal range for the study center; positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA positivity; positive for cytomegalovirus (CMV) DNA; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;\n4. Any unstable systemic disease, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ III), active bleeding, severe arrhythmias requiring drug treatment, liver, kidney, or metabolic disorders;\n5. Presence of malignant tumors other than large B-cell lymphoma, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, and other cancers with a disease-free survival of more than 5 years;\n6. Presence of gastric lymphoma, bulky disease, a history of CD19+ leukemia, or active autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.);\n7. Presence of uncontrolled active infections requiring treatment (e.g., sepsis, bacteremia, fungemia, viremia) (mild urinary tract infections or upper respiratory tract infections are exceptions), with the exception of prophylactic anti-infection treatment (for bacterial, fungal, viral infections, etc.);\n8. Subjects who have received systemic steroid treatment within 2 weeks before PBMC collection and are determined by the investigator to require long-term systemic steroid treatment during the treatment period (except for inhaled, local application, or physiological replacement doses \\[hydrocortisone ≤7 mg·d-1 or equivalent prednisone ≤5 mg·d-1 or dexamethasone ≤0.5 mg·d-1\\]);\n9. Subjects who have received anti-tumor treatment within 8 weeks or 5 half-lives (specific medications need to be assessed in detail) before PBMC collection, including chemotherapy, CD20-targeted therapy, etc.; local radiotherapy within 12 weeks;\n10. Subjects who have used granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks before PBMC collection or within at least 5 half-lives (whichever is shorter);\n11. Subjects who have received alendronate treatment within 6 months before PBMC collection, or who have received fludarabine, cladribine, or bendamustine treatment within 3 months before PBMC collection;\n12. Subjects who have undergone major surgery within 4 weeks prior to screening (as defined by \"Clinical Application Measures of Medical Technology\" and \"Grade 3 and 4 surgeries\") or who have not fully recovered from any previous invasive procedure;\n13. Subjects who have received a live vaccine within 28 days before PBMC collection;\n14. Pregnant or breastfeeding women, or those who plan to become pregnant during the treatment period or within 2 years after treatment, or male subjects whose partners plan to become pregnant within 2 years after male subject's cell injection;\n15. Subjects whom the investigator deems unsuitable to participate in this trial.","75 Years",{"count":63,"type":19},18,[65],"PHASE1","This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.",[68,30,69,70,71,35],"Diffuse Large B-cell-lymphoma","Follicular Lymphoma Grade 3B","PMBL","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements",[73,74,75,76,77],"autologous fast CAR-T","CD19","B cell lymphoma","subcutaneous injection","without lymphodepletion","2025-06-11",{"date":80,"type":45},"2025-06-13",{"date":82,"type":45},"2025-03-19",{"date":84,"type":19},"2026-05-11",{"name":86,"class":87},"Shanghai Exuma Biotechnology Ltd.","INDUSTRY",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":20,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":88},"100538174","phase-2-epcoritamab-epcor-containing-combination-salvage-therapy-followed-by-asct--epcor-consolidation-in-patients-with-relapsed-lbcl-100538174","NCT06287398","Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL","A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Confirmed diagnosis of DLBCL, Not-otherwise specified (NOS), Transformation of indolent B-cell lymphoma, High-grade B-cell lymphoma (HGBCL), NOS, Diffuse-large BCL (DLBCL)\u002F High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements or Follicular large B-cell lymphoma according to World Health Organization (WHO) 2016 or 2022 criteria that has relapsed or progressed after one line of chemoimmunotherapy\n3. Transplant eligible according to local assessment\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n5. Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5cm in longest axis or an extranodal site greater than 1.0cm in longest axis AND baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) scans must demonstrate positive lesion compatible with CT defined anatomical tumour sites\n6. Histological confirmation of tumour CD20 positivity, analysed by immunohistochemistry, on a pre-enrolment tissue sample performed after most recent prior therapy\n7. Adequate renal function\n\n   \\- Creatinine clearance greater than 45mL per min (Cockcroft Gault formula)\n8. Adequate hepatic function:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3x Upper Limit of Normal (ULN)\n   * Bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) or less than or equal to 3 if documented liver involvement and\u002For Gilbert's disease.\n9. Adequate haematologic function:\n\n   * Haemoglobin greater than or equal to 90g\u002FL (transfusion support permitted)\n   * Absolute neutrophil count greater than or equal to 1.0 x 109 per L; growth factor support allowed in case of bone marrow involvement\n   * Platelet count greater than 75 x 109 per L or greater than or equal to 50 x 109 per L if documented marrow involvement\n10. Able to take oral medications\n11. Adequate washout of prior therapies:\n\n    * At least 4 weeks since last dose of immunochemotherapy, radio-conjugated or toxin-conjugated compound, or other investigational anti-cancer therapy\n    * At least 6 weeks since chimeric antigen-receptor T-cell therapy\n12. Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n13. If receiving glucocorticoid treatment at screening, treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of Epcoritamab\n14. Before the first dose of Epcoritamab, during the trial and for 12 months after last administration of Epcoritamab, a woman must be either:\n\n    1. Not of childbearing potential, defined as: premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n    2. Of childbearing potential and practicing a highly effective method of birth control (as defined by the European Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials: e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that patient); true abstinence (when this is in line with the preferred and usual lifestyle of the patient) \\* If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 16b\n15. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of Epcoritamab\n16. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of Epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of Epcoritamab\n17. The patient understands the purpose of the trial and procedures required for the trial and is capable of giving signed informed consent which includes compliance with the requirements (no medical or psychiatric reason precluding participation) and restrictions listed in the informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n1. Diagnosis of primary Central Nervous System (CNS) lymphoma\n2. Active secondary CNS involvement of lymphoma at time of screening\n\n   \\- A prior history of secondary CNS lymphoma is allowed provided that it has been successfully treated and there are no features of recurrence.\n3. Prior autologous stem cell transplant\n4. 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 Prostate Specific Agent (PSA) level less than 0.1 ng per mL e. indolent lymphoma\n   5. Indolent lymphoma\n   6. Other malignancy that has been treated with curative intent and has remained in remission for 2 years\n5. Any prior therapy with a bispecific antibody targeting CD3 and CD20\n6. Uncontrolled systemic infection\n7. Known HIV infection\n8. Known active hepatitis B or C infection based on criteria below:\n\n   * Hepatitis B virus (HBV): Patients with positive HbsAg are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HbsAg require negative hepatitis B polymerase chain reaction (PCR) before enrolment and must be treated with antiviral therapy. Patients who are hepatitis B PCR positive will be excluded.\n   * Hepatitis C virus (HCV): If positive hepatitis C antibody, patient will need to have a negative hepatitis C ribonucleic acid (RNA) before enrolment. Patients who are hepatitis C RNA positive will be excluded.\n9. Seizure disorder, unless seizure-free for 12 months on established anticonvulsant therapy without the requirement for modification to anticonvulsants within the prior 12 months\n10. Known clinically significant cardiac disease, including:\n\n    1. Onset of unstable angina pectoris within 6 months of signing the patient informed consent form (PICF)\n    2. Acute myocardial infarction within 6 months of signing the PICF\n    3. Congestive heart failure (grade III or IV as classified by the New York Heart Association\n    4. Decreased ejection fraction of less than 45%\n11. Confirmed history or current autoimmune disease requiring permanent immunosuppressive therapy. Low-dose prednisolone (less than or equal to 10mg\u002Fday or equivalent) for rheumatoid arthritis or similar conditions is allowed.\n12. Exposed to live or live attenuated vaccine within 4 weeks prior to signing PICF\n13. Women who are pregnant or lactating.\n14. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n15. Known hypersensitivity or adverse reaction to rituximab, tocilizumab or any elements of DHAOx\n16. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial",{"count":97,"type":19},39,[99],"PHASE2","The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:\n\n* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R\u002FR) large B-cell lymphoma who achieve a complete remission prior to planned transplant?\n* Is consolidation epcoritamab after ASCT deliverable and safe?\n* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?\n* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.\n\nParticipants will undergo three phases in this trial:\n\n1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab\n2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.\n3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.",[102,103,104,30,105,106,107],"DLBCL - Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Large Cell Lymphoma, Relapsed","Follicular Large Cell Lymphoma","2024-07-19",{"date":110,"type":45},"2024-07-22",{"date":112,"type":45},"2023-12-11",{"date":114,"type":19},"2031-11",{"name":116,"class":51},"Australasian Leukaemia and Lymphoma Group"]