[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extranodal-marginal-zone-lymphoma-of-mucosa-associated-lymphoid-tissue\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extranodal-marginal-zone-lymphoma-of-mucosa-associated-lymphoid-tissue":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100379683","phase-1-study-of-kappa-chimeric-antigen-receptor-car-t-lymphocytes-co-expressing-the-kappa-and-cd28-cars-for-relapsedrefractory-kappa-non-hodgkin-lymphoma-and-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100379683",false,"NCT04223765","Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed\u002FRefractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma.","Phase 1 Study of the Administration of T Lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed\u002FRefractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma.","Note: During the period of cell procurement and CAR.κ.28 T cell production, subjects are allowed to receive additional standard of care chemotherapy to stabilize their disease if the treating physician feels it is in the subject's best interest. For subjects requiring bridging chemotherapy while awaiting manufacture of their CAR.κ.28 T-cells, details regarding treatment(s) administered including dose, frequency, number of cycles, etc. will be collected.\n\nInclusion Criteria for the Study\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in this study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Adults ≥18 years of age.\n3. Diagnosis of relapsed\u002Frefractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma OR histologically confirmed B-cell NHL, including the following types defined by WHO 2016:\n\n   Aggressive Lymphomas:\n   * DLBCL not otherwise specified (NOS)\n   * T cell\u002Fhistiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma\n   * Primary mediastinal (thymic) large B-cell lymphoma\n   * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; high grade B-cell lymphoma, NOS\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n   * Transformation of indolent lymphoma or CLL to DLBCL will also be included\n   * Burkitt lymphoma\n\n   Indolent Lymphomas:\n   * Follicular lymphoma grade 1-3b\n   * Splenic marginal zone lymphoma\n   * Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue\n   * Nodal marginal zone lymphoma\n   * Mantle cell lymphoma\n   * Subjects with central nervous system (CNS) disease will not be excluded as long as it has been stable for 3 months\n\n   Subjects with bone marrow only involvement are eligible\n4. Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study.\n5. Subjects who have received prior CD19-directed CAR therapies for relapsed\u002Frefractory disease are eligible for this study. However, at least 3 months must have passed since the subject received CD19 CAR-T cells.\n6. Patients with aggressive lymphomas must have relapsed or refractory disease after having received at least 2 prior lines of systemic therapy, including, at a minimum:\n\n   * An anti-CD20 monoclonal antibody\n   * An anthracycline containing chemotherapy regimen (if eligible)\n   * An autologous stem cell transplant (if eligible)\n7. For indolent lymphomas, subjects must have received at least 2 prior lines of therapy for their lymphoma\n8. Subjects with specifically relapsed\u002Frefractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma must have received at least 2 prior therapy regimens which can include, but not limited to:\n\n   * A combination of an anti-CD20 monoclonal antibody and an alkylating agent, OR\n   * A Bruton's Tyrosine Kinase Inhibitor, OR\n   * A BCL-2 inhibitor in combination with an anti-CD20 monoclonal antibody\n9. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial at the investigator's discretion.\n10. Kappa-positive expression on lymphoma or CLL\u002FSLL tissue sample, or kappa restriction on flow cytometry (archival or fresh) as confirmed by institutional hematopathology standard (result must be confirmed at the time of cell procurement).\n11. Karnofsky score of \\> 60%\n12. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Female subjects of childbearing potential will also be instructed to tell their male partners to use a condom.\n\nExclusion Criteria for the Study\n\nSubjects meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion and cell infusion):\n\n1\\. A history of intolerance to bendamustine or fludarabine. Note: subjects with known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide and fludarabine at the discretion of the clinical investigator.\n\n2 Subject is pregnant or lactating. 3 Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \\\u003C10 mg daily may be enrolled at discretion of investigator. 4 Active infection with HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy as well as no history of HIV. Subjects are required to have negative HIV antibody, negative HTLV1 and HTLV2 antibodies, negative hepatitis B surface antigen, and negative HCV antibody or viral load.\n\nEligibility Criteria to be Met Prior to Procurement\n\n1. Subject has signed a consent to undergo cell procurement.\n2. Evidence of adequate organ function as defined by:\n\n   * Total bilirubin \\\u003C1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\>1.5 mg\u002FdL if their conjugated bilirubin is \\\u003C1.5 × ULN)\n   * AST and ALT \\\u003C 5x ULN\n   * Pulse oximetry of \\>90% on room air\n   * Creatinine ≤ 2 x ULN\n3. Imaging results from within 120 days prior to procurement to assess presence of active disease.\n4. Confirmed kappa-positive expression on lymphoma or CLL\u002FSLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology.\n5. Subject has adequate cardiac function, defined as:\n\n   * No ECG evidence of acute ischemia\n   * No ECG evidence of active, clinically significant conduction system abnormalities\n   * Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant\n   * No uncontrolled angina or severe ventricular arrhythmia\n   * Left ventricular ejection fraction (LVEF) \\>40% as measured by ECHO, with no additional evidence of decompensated heart failure, performed within 30 days prior to procurement\n6. In women of child-bearing potential, negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for \\> 1 year.\n\nEligibility Criteria to be Met Prior to Lymphodepletion\n\n1. Written informed consent to enroll in the CAR-T cell therapy trial must be obtained prior to lymphodepletion.\n2. The last bridging therapy should be completed at least 3 weeks prior to lymphodepletion.\n3. Subjects who have received bridging therapy will be reassessed with imaging within 5 days prior to lymphodepletion and at least 3 weeks after bridging therapy. If a patient did not receive bridging chemotherapy, they will be imaged within 10 days prior to lymphodepletion.\n4. Adequate organ function per the following criteria are required prior to lymphodepletion:\n\n   * Adequate bone marrow function, as defined by:\n\n     * ANC \\>1.0 × 109\u002FL\n     * Platelets \\>50 × 109\u002FL unless related to lymphoma involvement (independent of transfusion within 7 days of lymphodepletion)\n   * Total bilirubin ≤1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\>1.5 mg\u002FdL if their conjugated bilirubin is \\\u003C1.5× ULN)\n   * AST and ALT ≤ 5× ULN\n   * Pulse oximetry of \\> 90% on room air\n   * Creatinine ≤2 x ULN\n   * If subjects display any clinical signs or symptoms of cardiac dysfunction after receiving bridging chemotherapy, they will undergo repeat ECG and ECHO to reassess their cardiac function and status\n5. In female subjects of childbearing potential, a negative serum pregnancy test within 72 hours prior to l ymphodepletion or documentation that the subject is post-menopausal or has been surgically sterilized.\n\n   Post-menopausal status must be confirmed with documentation of absence of menses for \\> 1 year.\n6. In subjects with CLL\u002FSLL, a bone marrow biopsy within 28 days prior to lymphodepletion.\n7. In subjects with WM\u002FLPL, a bone marrow biopsy within 90 days prior to lymphodepletion.\n8. Subjects must have autologous transduced activated T-cells that meet the Certificate of Analysis (CofA) acceptance criteria.\n9. Has not received any tumor vaccines within the previous six weeks prior to lymphodepletion.\n10. Has not received investigational agent or cancer-directed therapy within the previous 3 weeks, or 5 half-lives (whichever is shorter), prior to lymphodepletion.\n11. Subjects may not be receiving strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) up through 72 hours after the last dose of bendamustine, as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F for an updated list of strong inhibitors of CYP1A2\n12. Subject is not taking a prohibited or contraindicated medication listed in the protocol. Contraindicated medications should be discontinued at least two weeks prior to the scheduled lymphodepletion or by at least 5 half-lives of the contraindicated medication, whichever is shorter.\n13. No evidence of uncontrolled infection or sepsis.\n\nEligibility Criteria to be Met Prior to Cell Infusion After Lymphodepletion\n\n1. No evidence of uncontrolled infection or sepsis.\n2. Evidence of adequate organ function as defined by:\n\n   1. Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome\n   2. AST \\\u003C 5 × ULN\n   3. ALT \\\u003C 5 × ULN\n   4. Creatinine ≤ 3 x ULN\n3. Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator.\n4. Subject is a good candidate for treatment with CAR.κ.28 cell product per the clinical investigator's discretion.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. For this study, the anti-kappa light chain antibody has been changed so instead of floating free in the blood, a part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells. When an antibody is joined to a T cell in this way, it is called a chimeric receptor. The kappa light chain chimeric (combination) receptor-activated T cells are called ATLCAR.κ.28 cells. These cells may be able to destroy lymphoma cancer cells. They do not, however, last very long in the body so their chances of fighting the cancer are unknown.\n\nPrevious studies have shown that a new gene can be put into T cells to increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes an antibody called an anti-kappa light chain. This anti-kappa light chain antibody usually floats around in the blood. The antibody can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called kappa light chains.\n\nThe purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma. Initially, the study doctors will test different doses of the ATLCAR.κ.28, to see which dose is safer for use in lymphoma patients. Once a safe dose is identified, the study team will administer this dose to more patients, to learn about how these cells affect lymphoma cancer cells and identify other side effects they might have on the body.\n\nThis is the first time ATLCAR.κ.28 cells are given to patients with lymphoma. The Food and Drug Administration (FDA), has not approved giving ATLCAR.κ.28 as treatment for lymphoma. This is the first step in determining whether giving ATLCAR.κ.28 to others with lymphoma in the future will help them.",[26,27,28,29,30,31],"Mantle Cell Lymphoma","Follicular Lymphoma","Splenic Marginal Zone Lymphoma","Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Nodal Marginal Zone Lymphoma","Indolent Non-hodgkin Lymphoma",[33,34,35,36,37],"CAR T cells","Kappa","CD28","Lymphoma","T lymphocytes","RECRUITING","2026-01-16",{"date":41,"type":42},"2026-01-20","ACTUAL",{"date":44,"type":42},"2020-11-12",{"date":46,"type":20},"2043-03-22",{"name":48,"class":49},"UNC Lineberger Comprehensive Cancer Center","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":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100577338","phase-2-epcoritamab-in-patients-with-newly-diagnosed-marginal-zone-lymphoma-mzl-100577338","NCT06796998","Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)","Phase 2 Trial of Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)","Inclusion Criteria:\n\n1. Men and women aged 18 years or older at the time of signing informed consent.\n2. Able and willing to sign the informed consent form (ICF).\n3. Ability to comply with the trial protocol.\n4. Histologically confirmed Marginal Zone Lymphoma (MZL) of Extranodal Marginal Zone Lymphoma (EMZL), Nodal Marginal Zone Lymphoma (NMZL) and Splenic Marginal Zone Lymphoma (SMZL) subtypes presenting with stage I-IV disease.\n5. Previously untreated participants.\n\n   1. Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, participant has histologically confirmed MZL.\n   2. Participants who were previously treated with localized therapy (eg, radiation or surgery) and never received systemic therapy and present with recurrent disease are eligible upon histological confirmation of MZL.\n6. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures \\>1.5 cm in the longest diameter (LDi) and ≥1.0 cm in the longest perpendicular diameter as assessed by PET\u002FCT, CT or MRI, especially in extranodal sites, per response criteria for lymphomas (Cheson, et al., 2014). Imaging must be conducted within 6 weeks prior to the start of therapy.\n\n   1. Participants with skin EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that skin lesion measures ≥1.5 cm in diameter by tape measure and is documented by photo or there are ≥2 skin lesions measuring \\>1 cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL.\n   2. Participants with gastric EMZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assessed by multiple random gastric biopsies per Groupe d'Etude des Lymphomes de l'Adult (GELA) criteria (Ruskoné Fourmestraux, et al., 2011).\n   3. Participants with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that conjunctival lesion measures ≥1 cm in diameter by tape measure and is documented by photo or there are multiple conjunctival lesions measuring together \\>1.5 cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs to be histologically confirmed as MZL.\n   4. Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow (BM) infiltration of MZL is histologically confirmed.\n7. Participants will be asked to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy but this is not an exclusion criteria.\n\n   a. Participants with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible for participation provided participant is willing to undergo a BM biopsy or provide an archival BM biopsy that was obtained before the date of the first dose of study treatment; BM sample must show histologically confirmed infiltration of MZL\n8. Participant should have at least one of the following criteria for treatment initiation:\n\n   * Threatened extranodal organ function, especially for extranodal MZL\n   * Involvement of ≥3 nodal sites, each with diameter of ≥3 cm\n   * Any nodal or extranodal tumor mass with a diameter of ≥5 cm\n   * B symptoms (fever ≥38 degrees Celsius of unclear etiology, night sweats, weight loss \\>10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement.\n   * Risk of local compressive symptoms that may result in organ compromise\n   * Splenomegaly \\>13 cm or splenic lesion without splenomegaly and needs treatments (e.g., symptoms, cytopenias \\[hemoglobin (HgB) \\\u003C10 g\u002FdL and platelet count ≤ 80 × 10\\^9 platelets\u002FL attributable to lymphoma bone marrow infiltration, splenomegaly or autoimmunity\\], \\>5,000 lymphoma cells\u002Fmm3).\n   * Threatened organ function, especially for extranodal MZL\n   * Leukopenia attributed to MZL (leukocytes \\\u003C1,000 cells\u002Fmm3)\n   * Leukemia (\\>5,000 lymphoma cells\u002Fmm3)\n   * Requirement for transfusion or growth factor support attributed to lymphoma\n   * Involvement of 2 or more extranodal sites, with tumor\u002Flesion in each extranodal site ≥1 cm\n9. Life expectancy \\>3 months.\n10. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n11. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):\n\n    1. Absolute neutrophil count (ANC) ≥1.0 × 10\\^9 cells\u002FL.\n    2. Hemoglobin ≥8.0 g\u002FdL.\n    3. Platelet count ≥50 × 10\\^9 platelets\u002FL.\n    4. Total bilirubin ≤1.5 × 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 if ≤5 x ULN.\n    5. Alanine transaminase (ALT)\u002Faspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.\n    6. Creatinine within normal institutional limits, or\n\n       * calculated creatinine clearance ≥35 mL\u002Fmin by the Cockcroft-Gault Equation (Cockcroft, 1976)\n       * estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 using the Modification of Diet in Renal Disease formula for participants with creatinine levels above institutional normal (unless due to lymphoma)\n12. Willingness to avoid pregnancy during the trial and for at least 90 days after the last dose of the trial intervention. For more information on Contraception, please see Section 5.12.\n\nExclusion Criteria:\n\n1. Evidence of DLBCL transformation. Participants with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase (LDH), rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.\n2. History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Participants with dural MZL are eligible.\n3. Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).\n4. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (\\>20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1.\n\n   1. Steroids that are used for treatment of allergy or other underlying condition are permissible, but not steroids started to treat lymphoma. Participants receiving corticosteroids must be at a dose level ≤20 mg\u002Fday within 7 days of the trial intervention administration.\n   2. The use of inhaled corticosteroids is permitted\n   3. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n   4. Single dose of dexamethasone for nausea or B symptoms is permitted\n   5. Antibiotic treatment of H. pylori-positive gastric EMZL\n5. Allogeneic stem cell transplant or autologous stem cell transplant or chimeric antigen receptor (CAR) T-cell therapy for any indication\n6. Active graft versus host disease.\n7. Inadequate recovery from toxicity and\u002For complications from a major surgery before starting therapy.\n8. Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.\n9. Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.\n10. Chronic or current active infectious disease (including severe acute respiratory syndrome coronavirus (CoV) 2 (SARS-CoV-2)) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1.\n11. Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.\n\n    1. Inactivated influenza vaccinations may be given during the influenza season.\n    2. An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.\n12. Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional\n13. History of solid organ transplantation\n14. History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (Mabs)\n15. Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the epcoritamab, lenalidomide, or thalidomide formulation, including mannitol.\n16. Significant cardiovascular disease (eg, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 3 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n17. Known or suspected chronic active Epstein-Barr virus (EBV) infection\n18. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n19. History of progressive multifocal leukoencephalopathy (PML)\n20. Active hepatitis B infection\n\n    a. Patients who are hepatitis B surface antigen (HbsAg) negative and hepatitis B core antibody (HbcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation. Hepatitis B DNA must be negative prior to treatment with epcoritamab. Patients with chronic HBV infection who are at risk of viral reactivation (HBsAg positive and\u002For anti-hepatitis B core (anti-HBc) positive) must receive antiviral prophylaxis with nucleos(t)ide analogue with high barrier to resistance (tenofovir disoproxil fumarate, tenofovir alafenamide, or entecavir) as described in Section 7.2.4.5.\n21. Active hepatitis C infection\n\n    a. Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation\n22. History of autoimmune disease, including, but not limited to, myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n\n    1. Patients with a remote history of, or well-controlled, autoimmune disease with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the Investigator\n    2. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n    3. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n    4. Patients with a history of disease-related immune thrombocytopenic purpura, or autoimmune hemolytic anemia may be eligible\n    5. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * i. Rash must cover 10% of body surface area\n       * ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n       * iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months\n23. Patient has no known active SARS-CoV-2 infection. If a patient has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (e.g., PCR) test or 2 negative antigen test results at least 24 hours apart.\n\n    Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations. Patients 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    * 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.\n24. Patients with impaired decision-making capacity.",{"count":59,"type":20},25,[61],"PHASE2","The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).",[64,29,28,30],"Marginal Zone Lymphoma","2025-10-26",{"date":67,"type":42},"2025-10-28",{"date":69,"type":42},"2025-10-13",{"date":71,"type":20},"2031-04-15",{"name":73,"class":49},"Izidore Lossos, MD"]