NCT07350863

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

A Phase I, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of U69 in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	CXCR4 CCR9 CAR-T	CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection solution

Timeline

• Start date: 2026-06-25
• Primary completion: 2026-12-15
• Completion: 2028-07-15
• First posted: 2026-01-20
• Last updated: 2026-03-19

Locations

1 site across 1 country: China