Clinical Trial

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

Recruiting Early Phase 1
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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.
Trial Details
NCT Number NCT07429461
Lead Sponsor Zhejiang University
Collaborators: Bisheng (Beijing) Biotechnology Co., Ltd.
Conditions B-Cell Acute Lymphoblastic Leukemia
Enrollment 16 participants
Start Date 2026-02-28
Primary Completion 2027-12-31 (estimated)
Study Completion 2041-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-24