This phase I trial studies the side effects and best dose of donor-derived tumor associated antigen-specific T cells and how well they work in treating participants with acute lymphoblastic leukemia that has come back or does not respond to treatment. Tumor-associated antigen-specific T cells are immune system cells that may target cell proteins specific to tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02475707.
PRIMARY OBJECTIVES:
I. To determine the safety of one intravenous injection of donor-derived multi-tumor associated antigen (multiTAA)-specific T cells, administered as prophylaxis or treatment of acute lymphoblastic leukemia (ALL) post allogeneic hematopoietic stem cell transplant (HSCT).
II. To obtain information on the expansion, persistence and anti-tumor effects of adoptively transferred donor-derived multiTAA-specific T cells in patients with ALL.
III. To determine whether multiTAA-specific T cell infusions increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).
OUTLINE: This is a dose escalation study.
Participants receive donor-derived WT1/PRAME/NY-ESO-1/survivin-specific T-lymphocytes intravenously (IV) over 1-10 minutes on day 0. Beginning 4 weeks after infusion, participants who achieve partial response, complete response or stable disease may receive 6 additional doses every 4 weeks.
After completion of study treatment, participants are followed up at 3, 6, 9, and 12 months, and then annually for up to 4 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorBilal A. Omer