Phase 11b Study of UCD19 CAR T Cell Therapy in Adults With B-Cell Acute Lymphoblastic Leukemia in First Remission with Minimal Residual Disease

What this Trial Is About

Researchers are evaluating the safety and tolerability of CD19 directed CAR T cell therapy UCD19 CAR T in adults with B-cell acute lymphoblastic leukemia B-ALL who are in their first complete remission but still have minimal residual disease MRD positivity. This Phase 11b trial aims to find the maximum tolerated dose and to observe the treatments effects on survival and disease response over time. The trial started in January 2024 and is sponsored by the University of Colorado, Denver. Participants will first undergo apheresis to collect cells, followed by lymphodepleting chemotherapy. After chemotherapy, patients will receive an infusion of UCD19 CAR T cells. The infusion may be delayed up to seven days after chemotherapy if needed to resolve toxicities or for product release. The study includes a dose escalation phase with 10 patients, followed by a dose expansion phase with 12 additional participants treated at the maximum tolerated dose. During the study, participants will be monitored closely for adverse events, dose limiting toxicities, and treatment response at multiple time points up to 24 months after infusion. Assessments include blood tests, organ function checks, and weekly evaluations until 42 days post CAR T infusion. Participants must stay within one hour of the treatment center for at least four weeks after infusion for monitoring. The main outcomes measured are safety, overall response rate, survival, and event-free survival.

UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1