Allogeneic CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine After Matched Related Donor Hematopoietic Cell Transplant for the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia
City of Hope Medical Center
Abstract
This early phase I trial tests the safety and side effects of allogeneic CMV-specific CD19-CAR T cells plus CMV-MVA vaccine and how well it works in treating patients with high-risk acute lymphoblastic leukemia after a matched related donor (allogeneic) hematopoietic stem cell transplant (alloHSCT). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which 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, in this study, the T cells are cytomegalovirus (CMV) specific. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the CMV-specific T cells in the laboratory. The special receptor is called a 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. Vaccines made from three CMV tumor associated antigens, may help the body build an effective immune response to kill cancer cells. Giving allogeneic CMV-specific CD19-CAR T cells plus CMV-MVA vaccine after matched related alloHSCT may be safe, tolerable, and/or effective in treating patients with high-risk acute lymphoblastic leukemia. Phase: EARLY_PHASE1 Status: RECRUITING Conditions: Acute Lymphoblastic Leukemia Interventions: Allogeneic Hematopoietic Stem Cell Transplantation; Anti-CD19-CAR CMV-specific T-lymphocytes; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Computed Tomography; Echocardiography; Leukapheresis; Lumbar Puncture; Magnetic Resonance Imaging; Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Multigated Acquisition Scan; Positron Emission Tomography; Transplant Conditioning; X-Ray Imaging