City of Hope Medical Center
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.
PRIMARY OBJECTIVE: I. Assess the safety of administering autologous BAFFR-targeting CAR T cells (BAFFR\[EQ\]BBζ/EGFRt T cells) (also known as \[aka\], BAFFR-CAR T cells). SECONDARY OBJECTIVES: I. Evaluate the ability of BAFFR-CAR T cells to mediate clinical response in participants with B-ALL. II. Evaluate the level of residual disease in participants who achieve remission after BAFFR-CAR T cell treatment. III. Evaluate the duration of B cell aplasia as a surrogate for BAFFR-CAR T cell activity. IV. Evaluate the rate and severity of graft-versus-host disease (GVHD) in recipients of prior…
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Life expectancy ≥ 16 weeks * Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma * Relapsed/refractory disease. Minimal residual disease (MRD) relapse is allowed * Evidence of tumor expressing BAFF-R at any level either by flow or immun…
Given IV
Undergo blood and CSF specimen collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Receive bridging therapy
Undergo chest x-ray
Undergo CT or PET/CT
Given IV
Undergo ECHO
Given IV
Undergo leukapheresis
Undergo brain MRI
Undergo MUGA
Undergo PET/CT
Undergo liver ultrasonographic elastography