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Brief Title: Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
Official Title: Clinical Study of CLDN18.2-targeting Chimeric Antigen Receptor-modified Autologous T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
Study ID: NCT05472857
Brief Summary: This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
Detailed Description: Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (IMC002). Following manufacture of the drug product, subjects will receive preconditioning prior to IMC002 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Changhai Hospital, Shanghai, Shanghai, China
Name: Luo Tianhang, MD
Affiliation: Changhai Hospital
Role: PRINCIPAL_INVESTIGATOR