RecruitingPhase 1Phase 2NCT06987916

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma


Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Enrollment

50 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .


Eligibility

Min Age: 2 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called U01 (ssCART-19) — a treatment that reprograms your own immune cells to find and destroy B-cell lymphoma — in people whose cancer has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 2–75 years old (guardians must co-sign for anyone under 18) - You have been diagnosed with B-cell lymphoma - Your cancer did not respond to first-line therapy or came back within 12 months, OR you have relapsed or refractory B-cell lymphoma after second-line therapy **You may NOT be eligible if...** - You have not tried prior standard treatments first - You have a different type of lymphoma that is not B-cell - You do not meet the health and performance requirements - You are pregnant 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.

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Interventions

BIOLOGICALssCART-19

autologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene


Locations(1)

Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)

Shanghai, Shanghai Municipality, China

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NCT06987916


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