nctId: NCT06343376 id: I-3641523 id: NCI-2024-01818 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-02 date: 2024-04-02 name: Roswell Park Cancer Institute class: OTHER 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. 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Cyclophosphamide name: Echocardiography name: EGFRt/19-28z/IL-12 CAR T-lymphocytes name: Fludarabine Phosphate name: Leukapheresis name: Multigated Acquisition Scan name: Positron Emission Tomography measure: Incidence of adverse events measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi) measure: Incidence of CR/CRi + partial response (PR) (ORR) measure: Event free survival measure: Overall survival measure: Progression-free survival measure: Modified T-cell persistence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Francisco J. Hernandez-ILizaliturri role: CONTACT phone: 716-845-1642 email: Francisco.Hernandez@RoswellPark.org name: Francisco J. Hernandez-ILizaliturri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False