protocolSection identificationModule nctId: NCT06343376, orgStudyIdInfo id: I-3641523, secondaryIdInfos id: NCI-2024-01818, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3641523, type: OTHER, domain: Roswell Park Cancer Institute, briefTitle: Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous 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. 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 to the T cells 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 for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies., conditionsModule conditions: Recurrent Chronic Lymphocytic Leukemia, conditions: Recurrent Diffuse Large B-Cell Lymphoma, conditions: Recurrent Follicular Lymphoma, conditions: Recurrent High Grade B-Cell Lymphoma, conditions: Recurrent Mantle Cell Lymphoma, conditions: Recurrent Transformed Chronic Lymphocytic Leukemia, conditions: Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, conditions: Refractory Chronic Lymphocytic Leukemia, conditions: Refractory Diffuse Large B-Cell Lymphoma, conditions: Refractory Follicular Lymphoma, conditions: Refractory High Grade B-Cell Lymphoma, conditions: Refractory Mantle Cell Lymphoma, conditions: Refractory Transformed Chronic Lymphocytic Leukemia, conditions: Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Cyclophosphamide, interventions name: Echocardiography, interventions name: EGFRt/19-28z/IL-12 CAR T-lymphocytes, interventions name: Fludarabine Phosphate, interventions name: Leukapheresis, interventions name: Multigated Acquisition Scan, interventions name: Positron Emission Tomography, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells, secondaryOutcomes measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi), secondaryOutcomes measure: Incidence of CR/CRi + partial response (PR) (ORR), secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Modified T-cell persistence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Francisco J. Hernandez-ILizaliturri, role: CONTACT, phone: 716-845-1642, email: Francisco.Hernandez@RoswellPark.org, contacts name: Francisco J. Hernandez-ILizaliturri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False