Spots Global Cancer Trial Database for Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
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Trial Identification
Brief Title: Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
Official Title: A Phase I Clinical Study of Anti-CD19 CAR-T Therapy (pCAR-19B) in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
Study ID: NCT04888442
Interventions
Study Description
Brief Summary: This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in adults with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Detailed Description: This is a single-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 adults with relapsed or refractory B-ALL.pCAR-19B will be infused to the subject by intravenous infusion.
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Contact Details
Name: Jianfeng Zhou, M.D. Ph.D
Affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Role: PRINCIPAL_INVESTIGATOR
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