[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-b-cell-non-hodgkin-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,69,93,120,143,166],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100633887","phase-1-pomalidomide-after-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-cd19-b-cell-leukemia-or-lymphoma-100633887",false,"NCT07532525","Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma","A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed\u002FRefractory CD19+ B-Cell Leukemias and Lymphomas","Inclusion Criteria:\n\n* Subject must have had a histologically or cytologically confirmed R\u002FR CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R\u002FR CD19+ Bcell leukemias and lymphomas.\n* Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.\n* \\>= 18 years in age at time of enrollment\n* Subject is able to swallow pills\u002Ftablets\n* Karnofsky or Lansky performance score of \\>= 50%\n* Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (granulocyte colony stimulating factor allowed)\n* Platelets \\>= 50,000\u002Fmm\\^3 (transfusion independent for \\>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \\[thrombopoietin (TPO) mimetics allowed\\])\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) per institution\n* Alanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) =\\\u003C 3 x institutional ULN per institution\n* Serum albumin \\>= 2.0 g\u002FdL\n* Creatinine clearance (Cockcroft-Gault equation) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n* Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program\n* Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide\n\nExclusion Criteria:\n\n* Patients with known progressive or refractory disease.\n* The following transplant or CAR T-related events are excluded:\n\n  * Active grade \\>= 2 acute or chronic graft versus host disease (GVHD)\n  * Active cytokine release syndrome (CRS) grade \\>= 2\n  * Active immune effector cell associated neurotoxicity (ICANS) grade \\>= 2\n* Subject receiving \\>= 0.25 mg\u002Fkg\u002Fday of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine.\n* Patient who smokes cigarettes.\n* Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS\u002FICANS is allowed within the prior 28 days\n* Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment\n* Stem cell transplant or rescue following most recent CD19CART therapy\n* History of allergic reactions to pomalidomide or any of the excipients and any similar compounds\n* Intercurrent illness or conditions:\n\n  * Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed\n  * Active grade \\>= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded\n  * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded\n  * History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment\n* Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug\n* HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia\u002Flymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.",[26,27,28,29],"Recurrent B Acute Lymphoblastic Leukemia","Recurrent B-Cell Non-Hodgkin Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory B-Cell Non-Hodgkin Lymphoma","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":20},"2026-07-01",{"date":38,"type":20},"2028-08",{"name":40,"class":41},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100430991","phase-1-cd19-directed-car-t-cell-therapy-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100430991","NCT04892277","CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Phase I Dose Escalation Trial of CD19 Directed Chimeric Antigen Receptor T Cell Therapy in the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory CD19+ B cell malignancies of the one of the following histopathology:\n\n  * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease defined as:\n\n    * Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had \\>= one prior treatment, including prior BTK inhibition\n    * Demonstration of progressive or stable disease by positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma.\n    * Measurable disease defined as measurable by CT portion of a PET\u002FCT: To be considered measurable, the must be at least one lesion that has a single diameter of (\\>1.5 cm Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\n  * Biopsy proven SLL or flow cytometry proven CLL; relapsed disease defined as:\n\n    * \\>= two prior lines of therapy, and\u002For \\>= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib). Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.\n    * Demonstration of progressive or stable disease by PET\u002FCT or CT criteria according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL2018) criteria\n    * Measurable disease by CT portion of a PET\u002FCT where at least one lesion has a single diameter of \\>1.5 cm or peripheral blood absolute blood lymphocyte count (ALC) of \\> 5000. Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Hemoglobin \\>= 8.0 g\u002FdL (=\\\u003C 14 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 500\u002Fmm\\^3 (=\\\u003C 14 days prior to registration)\n* Platelet count \\>= 30,000\u002Fmm\\^3 (=\\\u003C 14 days prior to registration)\n* Total bilirubin =\\\u003C 2.0 mg\u002FdL (with the exception of subjects with Gilbert's syndrome. Subjects with Gilbert's syndrome may be included if their total bilirubin is =\\\u003C 3.0 x upper limit of normal (ULN) and direct bilirubin =\\\u003C 1.5 x ULN) (=\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 14 days prior to registration)\n* Prothrombin time (PT) \u002F international normalized ratio (INR) and\u002For activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding, and no recent deep venous thrombosis\u002Fpulmonary embolism (DVT\u002FPE) within the last 6 months of enrollment) (=\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance \\>= 45 ml\u002Fmin using the Cockcroft-Gault formula (=\\\u003C 14 days prior to registration)\n* Cardiac ejection fraction \\>= 50% and no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan\n* Baseline oxygen saturation \\>= 92% on room air\n* Negative serum pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Women patients of child bearing potential, including women with tubal ligations, must commit to using use 2 highly effective forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) for the duration of the study and for 12 months following IC19\u002F1563 therapy\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Women of childbearing potential who are unwilling to employ highly effective contraception\n* Sexually active males who are not willing to use contraception during the study and for \\>= 12 months after IC19\u002F1563 therapy\n* Patients who are able to obtain market approved CD19 CAR T-cell therapies\n* Live vaccine =\\\u003C 6 weeks prior to start of registration\n* Autologous stem cell transplant =\\\u003C 6 weeks of registration\n* History of allogenic stem cell transplant if was performed less than 100 days prior to registration, if patients have active graft-versus host disease (GVHD) or are if patients are on chronic immunosuppression. Patients with allogeneic transplantation more than 100 days prior to registration, with no active GVHD and who are not on immunosuppression are eligible\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n* Any form of primary immunodeficiency such as severe combined immunodeficiency disease\n* Current need of systemic corticosteroid therapy, in doses over 20 mg \u002Fday of prednisone or equivalent forms of steroids\n* History of severe immediate hypersensitivity reaction to CART19, stem cell infusion dimethyl sulfoxide (DMSO) or any of the CAR-T cryopreservation ingredients\n* History of malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast) or early stage cancers (Stage I or II), unless disease free for \\>= 2 years\n* Clinically significant active infection (e.g. simple urinary tract infection \\[UTI\\], bacterial pharyngitis allowed) or currently receiving IV antibiotics or have received IV antibiotics =\\\u003C 7 days prior to registration. Note: prophylactic antibiotics, antivirals and antifungals are permitted\n* Known history of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with a 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. Prophylactic antiviral therapy should be considered per institutional guidelines\n* History of any of the following cardiovascular conditions =\\\u003C 6 months:\n\n  * Class III or IV heart failure as defined by the New York Heart Association (NYHA)\n  * Cardiac angioplasty or stenting\n  * Myocardial infarction\n  * Unstable angina\n  * Or other clinically significant cardiac disease\n* Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that, in the judgment of the investigator, would make the subject inappropriate for entry into the study\n* Concurrent cancer therapy. The following are exceptions:\n\n  * Treatment with therapies may continue at time of registration; however, the washout period must be met prior to leukapheresis\n  * Treatment with any other investigational agent may continue at time of registration provided last date of treatment is =\\\u003C 14 days prior to leukapheresis.",{"count":51,"type":20},25,[23],"This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19\u002F1563 treatment. IC19\u002F1563 may help treat patients with relapsed\u002Frefractory B cell malignancies.",[27,55,56,57,29,58,59,60],"Recurrent Chronic Lymphocytic Leukemia","Recurrent Small Lymphocytic Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Small Lymphocytic Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","2026-06-05",{"date":33,"type":34},{"date":64,"type":34},"2022-10-03",{"date":66,"type":20},"2040-03-27",{"name":68,"class":41},"Mayo Clinic",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100638264","a-cognitive-training-intervention-for-improving-cognitive-and-neurological-outcomes-in-patients-undergoing-treatment-for-relapsed-or-refractory-multiple-myeloma-or-b-cell-non-hodgkin-lymphoma-100638264","NCT07609030","A Cognitive Training Intervention for Improving Cognitive and Neurological Outcomes in Patients Undergoing Treatment for Relapsed or Refractory Multiple Myeloma or B-cell Non-Hodgkin Lymphoma","Intervention to Enhance Cognitive Augmentation and Neuroplasticity (I-CAN)","Inclusion Criteria:\n\n* Patients \\>= 18 years of age\n* Diagnosed with relapsed\u002Frefractory multiple myeloma (MM) or B-cell non-Hodgkin lymphoma (B-NHL)\n* Expected to receive an Food and Drug administration (FDA)-approved CAR-T cellular treatment\n* English literacy\n\nExclusion Criteria:\n\n* Patients expected to live \\\u003C 6 months\n* Patients with major medical disorder known to affect cognition, such as stroke, encephalitis, traumatic brain injury, brain surgery\n* Confirmed Alzheimer disease or other dementia\n* Previous central nervous system (CNS) radiation\n* Active intrathecal therapy at time of enrollment",{"count":77,"type":20},90,[79],"NA","This clinical trial evaluates whether an online cognitive training intervention (Intervention to enhance Cognitive Augmentation and Neuroplasticity \\[I-CAN\\]), delivered before and after treatment with chimeric antigen receptor T-cell therapy, works to improve cognitive and neurological outcomes in patients with multiple myeloma or B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Cancer treatment can have significant short and long-term side effects, including cognitive and neurological side effects such as impairments in attention, memory, language, and executive function. The I-CAN program is a form of cognitive training. Cognitive training is a therapeutic approach designed to improve and restore cognitive functioning, based on the brain's ability to reorganize and form new neural connections to accomplish tasks. I-CAN provides five core elements necessary for training the brain to create new neural connections including speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. The I-CAN intervention, when delivered before and after therapy, may help reduce the cognitive side effects of treatment in patients with relapsed or refractory multiple myeloma or B-cell non-Hodgkin lymphoma.",[27,82,29,83],"Recurrent Multiple Myeloma","Refractory Multiple Myeloma","2026-05-19",{"date":86,"type":34},"2026-05-27",{"date":88,"type":34},"2026-04-28",{"date":90,"type":20},"2027-12-31",{"name":92,"class":41},"Ohio State University Comprehensive Cancer Center",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100460189","phase-1-testing-the-combination-of-nivolumab-and-astx727-for-relapsed-or-refractory-b-cell-lymphoma-100460189","NCT05272384","Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma","A Phase 1 Study of Nivolumab in Combination With ASTX727 in B-cell Lymphoma (NHL or HL) With an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma (HL)","Inclusion Criteria:\n\n* Dose Escalation: Histologically confirmed relapsed or refractory B cell lymphoma (non-Hodgkin lymphoma \\[NHL\\] or Hodgkin lymphoma \\[HL\\])\n* Dose Expansion: Patients must have histologically confirmed relapsed or refractory DLBCL or HL\n* Patients with DLBCL must have failed at least first line chemotherapy and must be transplant ineligible (either secondary to performance status or lack of adequate disease control or patient preference). Patients may be relapsed after autologous or allogeneic stem cell transplant (SCT), or after chimeric antigen receptor (CAR)-T cell therapy\n* In dose escalation patients with HL or B cell NHL other than DLBCL must have relapsed after at least 2 lines of therapy and have no other curative options left. HL patients must be brentuximab vedotin refractory or intolerant. In dose expansion, patients with classic HL must have relapsed after at least 2 lines of therapy, and had autologous stem cell transplantation (ASCT), be ineligible for ASCT, or have refused ASCT. Prior treatment with checkpoint inhibitor is allowed\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of nivolumab in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG)\u002FKarnofsky performance status =\\\u003C 2 (Karnofsky \\>= 70%)\n* Leukocytes \\>= 1,500\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Absolute neutrophil count \\>= 1,000\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Platelets \\>= 75,000\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Serum creatinine =\\\u003C 1.5 x ULN OR creatinine clearance (CrCl) \\>= 50 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior malignancy that has completed treatment and or in remission for at least 3 years, or non-melanoma skin cancer or in situ cancer are eligible for this trial. Patients with concurrent malignancy or recent treatment for a concurrent malignancy are not eligible\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* The effects of nivolumab and ASTX727 on the developing human fetus are unknown. For this reason and because DNMTi agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use a highly effective contraception method to avoid pregnancy during treatment with ASTX727 and for at least 6 months after the last dose of investigational drug and must agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to highly-effective contraceptive measures of birth control and not to father a child while receiving treatment and for a period of 3 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n\n  * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\nWOCBP receiving ASTX727 will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product. Men receiving ASTX727 and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 3 months after the last dose of investigational product. WOCBP receiving nivolumab as a single agent will be instructed to adhere to contraception for a period of 5 months after the last dose. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately\n\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (2 weeks for Revlimid, 6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients 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\n* Patients who have had prior treatment with anti-PD-1\u002FPD-L1 inhibitors or anti CTLA4 antibodies and were permanently discontinued from further treatment because of an adverse event. All other prior therapies are permissible. Prior checkpoint inhibitor therapy is allowed if there was no discontinuation due to adverse event\n* Patients who are receiving any other investigational agents\n* Patients with known brain metastases or leptomeningeal metastases may be excluded because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or nivolumab, including severe hypersensitivity reaction to any monoclonal antibody\n* Patients with uncontrolled intercurrent illness\n* Patients with cognitive or other impairment that would prevent compliance with study requirements\n* Pregnant women are excluded from this study because ASTX727 is a DNMTi agent and nivolumab is a PD-L1 inhibitor 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 ASTX727 and nivolumab, breastfeeding should be discontinued if the mother is treated with ASTX727 and nivolumab\n* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome (GBS), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study",{"count":101,"type":20},32,[23],"This phase I trial tests the safety, side effects, and best dose of nivolumab in combination with ASTX727 in treating B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ASTX727 consists of the combination of decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving nivolumab in combination with ASTX727 may shrink and stabilize cancer.",[27,105,106,29,107,108],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Hodgkin Lymphoma","2026-05-12",{"date":111,"type":34},"2026-05-13",{"date":113,"type":34},"2022-11-03",{"date":115,"type":20},"2027-06-28",{"name":117,"class":118},"National Cancer Institute (NCI)","NIH",9,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":42},"100614752","phase-1-trial-of-onc-plureceptor-nk-cells-with-epcoritamab-and-tafasitamab-for-patients-with-recurrent-or-refractory-b-cell-non-hodgkin-lymphoma-100614752","NCT07283679","Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma","Phase I\u002FII Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Patients with R\u002FR DLBCL or FL with all of the following:\n\n   Failure of \\>\u002F= 2 prior lines of therapy, or an autologous or allogeneic stem cell transplant.\n\n   Prior failure of CAR-T or not eligible for CAR-T cells.\n2. Tumor biopsy positive for CD19 or CD20 at \\>\u002F= 1% by immunohistochemistry or flow cytometry.\n3. Age 18-80 years.\n4. Karnofsky performance status \\>\u002F=60%.\n5. Absolute neutrophil count \\>\u002F=500\u002Fmm3 and platelet count \\>\u002F=50,000\u002Fmm3.\n6. Serum creatinine clearance (CrCl) \\>\u002F=30 ml\u002Fmin, estimated using the Cockcroft-Gault equation:\n\n   Estimated creatinine clearance = (140-age \\[years\\]) x weight (kg) (x Fa) \u002F serum creatinine (mg\u002FdL) x 72 \\[a where F=0.85 for females and F=1 for males\\].\n7. Adequate hepatic function (ALT and\u002For AST \\\u003C\u002F=3 x upper limit of normal (ULN); bilirubin and ALP \\\u003C\u002F=2 x ULN). Patients with cancer involvement of the liver and elevation of ALT, AST, bilirubin, and\u002For ALP \\\u003C\u002F= 5 x ULN are eligible, per PI discretion.\n8. Adequate pulmonary function with FEV1, FVC and DLCO (corrected for hemoglobin and volume) \\>\u002F=50%.\n9. Adequate cardiac function with left ventricular ejection fraction \\>\u002F=40%, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n10. If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.\n11. Female participants of non-childbearing potential must meet at least one of the following criteria:\n\n    i. Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n\n    ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    o Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. See Appendix B. Highly effective methods of contraception include the following:\n\n    iv. Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    o Men treated or enrolled in this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while in the study. If the male participant fathers a child or suspects that he has fathered a child while in the study, he must immediately notify his doctor.\n12. Agree to sign the consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies\n\nExclusion Criteria:\n\n1. Lymphoma in CR with no measurable sites of disease.\n2. Major surgery \\\u003C4 weeks prior to first dose of study drug.\n3. Any other severe or uncontrolled disease or condition that might increase the risk associated with study participation.\n4. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n5. Grade \\>\u002F= 3 non-hematologic toxicity from prior therapy that has not improved to grade \\\u003C\u002F= 2.\n6. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA.\\>\u002F=10,000 copies\u002FmL, or \\>\u002F=2,000 IU\u002FmL), or hepatitis C (detectable viral load by HCV RNA PCR)\n7. Active infection requiring parenteral antibiotics.\n8. HIV infection.\n9. Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.\n10. Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid).\n11. Life expectancy \\\u003C\u002F= 6 months.\n12. Active and uncontrolled neurological disorder.\n13. Patients receiving systemic steroid therapy at the time of enrollment (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n14. Patients receiving immunosuppressive therapy.",{"count":128,"type":20},30,[23,130],"PHASE2","The goal of this clinical research study is to learn if ONC-PluReceptor NK cell therapy (combined with the monoclonal antibody therapies epcoritamab and tafasitamab) can help to control relapsed or refractory B-cell Non-Hodgkin Lymphoma. The safety of this treatment will also be studied.",[27,133],"Refractory B-cell Non-Hodgkin Lymphoma","2026-04-27",{"date":136,"type":34},"2026-05-01",{"date":138,"type":34},"2026-02-24",{"date":140,"type":20},"2033-09-30",{"name":142,"class":41},"M.D. Anderson Cancer Center",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":42},"100500873","phase-1-genetically-modified-t-cells-cmv-specific-cd19-car-t-cells-plus-a-vaccine-cmv-mva-triplex-for-the-treatment-of-intermediate-or-high-grade-b-cell-non-hodgkin-lymphoma-100500873","NCT05801913","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma","A Pilot \u002F Feasibility Study of Autologous CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine in Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age: \\>= 18 years\n* Karnofsky Performance Status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients requiring treatment for relapsed or refractory intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) who are not eligible for, or who refuse, or have previously received autologous hematopoietic cell transplantation (autoHCT)\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to leukapheresis, lymphodepleting chemotherapy, steroids or tocilizumab, smallpox vaccine and any other MVA-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet these requirements at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet these requirements at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are \\>= 50% of cellularity) (Transfusions and growth factors must not be used to meet these requirements at initial screening)\n* Left ventricular ejection fraction \\>= 45% within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic stem cell transplant unless the participant has recovered from transplantation and does not have active graft versus host disease (GVHD)\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg\u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to lymphodepleting chemotherapy and\u002For CAR T-cell therapy per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease\n\n  * Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cell \\[WBC\\]\u002Fmm\\^3 and no blasts in cerebral spinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":151,"type":20},15,[23],"This phase I trial studies the safety and feasibility of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T cells in combination with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following lymphodepletion in treating patients with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refectory). CAR T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine may help prevent the cancer from coming back.",[155,156,27,29],"High Grade B-Cell Non-Hodgkin's Lymphoma","Intermediate Grade B-Cell Non-Hodgkin's Lymphoma","2026-03-03",{"date":159,"type":34},"2026-03-05",{"date":161,"type":34},"2023-09-29",{"date":163,"type":20},"2028-12-30",{"name":165,"class":41},"City of Hope Medical Center",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":189,"locationsCount":42},"100472496","phase-1-genetically-modified-t-cells-cmv-specific-cd19-car-t-cells-plus-a-vaccine-cmv-mva-triplex-following-stem-cell-transplantation-for-the-treatment-of-intermediate-or-high-grade-b-cell-non-hodgkin-lymphoma-100472496","NCT05432635","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","Pilot\u002FFeasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study PI approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limits of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are =\\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Left ventricular ejection fraction \\>= 45 percent within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior autologous\u002Fallogeneic stem cell transplant\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg \u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to myeloablative HSCT per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cells \\[WBC\\] \u002F mm\\^3 and no blasts in cerebrospinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years.\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Procedures (including compliance issues related to feasibility\u002Flogistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":151,"type":20},[23],"This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.",[177,178,179,27,105,180,181,182],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Mantle Cell Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Transformed Non-Hodgkin Lymphoma","2026-02-20",{"date":185,"type":34},"2026-02-23",{"date":187,"type":34},"2023-08-01",{"date":163,"type":20},{"name":165,"class":41}]