RecruitingEarly Phase 1NCT07429461

Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

Early Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SYNCAR-100 in the Treatment of CD19-Positive Relapsed or Refractory Acute B-Lymphoblastic Leukemia (R/R B-ALL)

Sponsor

Zhejiang University

Enrollment

16 participants

Start Date

Feb 28, 2026

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

Summary

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Participants who have signed the informed consent form will undergo screening against the inclusion and exclusion criteria. Eligible participants will receive study drug administration once weekly for a total of four doses, followed by a 1-year safety and efficacy follow-up observation period. After the completion of the study, long-term follow-up may be required for participants to monitor their health and survival status until 15 years post-treatment, or until the occurrence of patient death, loss to follow-up, or withdrawal of consent.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called SYNCAR-100 for people with relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL) — a type of blood cancer that has come back or stopped responding to treatment. CAR-T therapy uses the patient's own immune cells that have been re-engineered in a laboratory to attack cancer cells. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed B-cell ALL that has relapsed or not responded to at least 2 rounds of chemotherapy or previous CAR-T or stem cell transplant - Your cancer cells express a protein called CD19 confirmed by lab testing - You are in adequate health for treatment (Karnofsky score ≥ 70) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your cancer cells do not express CD19 - Your disease has not relapsed or become refractory - You are too unwell to participate (Karnofsky score below 70) 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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