U69-CART-Cells For R/R T-ALL

Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.

NCT Number	NCT07350863
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
Enrollment	12 participants
Start Date	2026-06-25
Primary Completion	2026-12-15 (estimated)
Study Completion	2028-07-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-19