Spots Global Cancer Trial Database for A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
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Trial Identification
Brief Title: A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Official Title: A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Study ID: NCT05396300
Interventions
Study Description
Brief Summary: This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Detailed Description: This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with CEA-positive advanced malignant solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12-24 subjects with CEA-positive advanced malignant solid tumors.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang, China
Contact Details
Name: Weijia Fang, M.D
Affiliation: The First Affiliated Hospital, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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