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

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

Trial Details

NCT ID

NCT07429461

Phase

EARLY_PHASE1

Sponsor

Zhejiang University

Status

RECRUITING

Cancer Type

Leukemia

Interventions

• SYNCAR-100 Injection

Locations (sample)

• Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

• Aged 18 to 75 years (inclusive), of any gender.
• Karnofsky Performance Status score ≥ 70.
• Estimated life expectancy ≥ 12 weeks.
• Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.

For full eligibility, visit ClinicalTrials.gov.

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