UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
This open-label, single arm Phase I trial aims to determine the safety and tolerability of
anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults B-ALL
that are in first complete remission with minimal residual disease (MRD) positivity. This
trial will enroll 10 patients for apheresis and treatment with lymphodepleting chemotherapy
followed by UCD19 CAR T cell infusion. Patients will be assessed for dose limiting toxicities
(DLTs) (within 42 days after CAR T infusion), duration of B cell aplasia, overall response
rate (at 1-, 3-, 6- and 12-months), and overall survival and event free survival (at 12- and
24- months) post UCD19 CAR T infusion.