RecruitingPhase 1NCT07350863

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)


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

12 participants

Start Date

Jun 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy — called U69-CART — designed to treat relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL), a rare and difficult-to-treat blood cancer. The therapy uses the patient's own immune cells, genetically re-engineered to seek and destroy cancer cells that carry a protein called CCR9. **You may be eligible if...** - You are 15–75 years old - You have confirmed relapsed or refractory T-ALL or T-LBL with no remaining standard treatment options - Your cancer cells are confirmed to express the CCR9 protein - You are in reasonably good physical health (ECOG 0–2) with expected survival over 3 months - Your organs (heart, liver, kidneys) are functioning at acceptable levels **You may NOT be eligible if...** - You have had prior CAR-T therapy targeting CCR9 - You have leukemia in the brain causing symptoms - You have active hepatitis B, C, HIV, CMV, or EBV infections - You have had another cancer within 3 years (with some exceptions) - You have had a stem cell transplant from another donor within 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCXCR4 CCR9 CAR-T

CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection solution


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07350863