This phase I trial tests the safety and side effects of B-cell activating factor receptor (BAFFR) chimeric antigen receptor (CAR) T cells and how well they work in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell lymphoblastic lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy, such as BAFFR-CAR T cells, 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 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. Giving BAFFR-CAR T cells may be safe, tolerable and/or effective in treating patients with relapsed or refractory B-cell ALL and B-cell lymphoblastic lymphoma.
Documented informed consent of the participant and/or legally authorized representative
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age ≥ 18 years
Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment
Immunosuppressant medications within 1 month prior to protocol enrollment
Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone ≤ 7.5 mg /day or equivalent) is allowed
Auto-immune disease or active graft-versus-host disease (GvHD) within 3 months prior to protocol enrollment requiring systemic immunosuppressant therapy
Single group
Autologous BAFFR-targeting CAR T Cells
Biological/VaccineGiven IV
Biospecimen Collection
Procedure/SurgeryUndergo blood and CSF specimen collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration and biopsy
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow aspiration and biopsy
Bridge Therapy
Procedure/SurgeryReceive bridging therapy
Chest Radiography
Procedure/SurgeryUndergo chest x-ray
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Cyclophosphamide
DrugGiven IV
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Fludarabine
DrugGiven IV
Leukapheresis
Procedure/SurgeryUndergo leukapheresis
Magnetic Resonance Imaging
Procedure/SurgeryUndergo brain MRI
Multigated Acquisition Scan
Procedure/SurgeryUndergo MUGA
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Ultrasonographic Elastography
Procedure/SurgeryUndergo liver ultrasonographic elastography
Incidence of adverse events
Will be graded using Common Terminology Criteria for Adverse Events version 5.0, American Society for Transplantation and Cellular Therapy Consensus Criteria on Cytokine Release Syndrome/Neurotoxicity, graft-versus-host disease (GVHD) criteria, and Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome identification and grading. Will be summarized by organ involved, severity, time of onset, and attribution.
Dose-limiting toxicity
Will be described individually.
Disease response rate
Will be defined as complete response (CR) or CR with incomplete blood count recovery or CR with partial hematological recovery. Will be evaluated using European LeukemiaNet criteria. Rates and associated 95% binomial exact confidence limits will be estimated.
Minimal residual disease negative rate
Will be defined by malignant cells \< 0.01% by flow cytometry or clonoSEQ. Rates and associated 95% binomial exact confidence limits will be estimated.
Duration of B-cell aplasia
Will be measured by serum immunoglobulin G level. Will be summarized by descriptive statistics.
Severity of GVHD in recipients of prior allogeneic hematopoietic stem cell transplantation
Will be defined per Keystone criteria for acute GVHD and revised National Institutes of Health consensus on grading of chronic GVHD. Competing risk method will be used to estimate.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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