Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers

Summary

This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic or other specified digestive system cancers.

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 (CT041). Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Sponsor

CARsgen Therapeutics Co., Ltd.

Status of enrollment

Accepting new patients

Ages Eligible for Study

Adults ages 18 - 76

Genders Eligible for Study

Females and males

Disease indication

Gastric, pancreatic or other specified digestive system cancers

Principal Investigator

Julia Carnevale, MD

Contact

Marissa Gin

[email protected]

 

Additional study eligibility details can be found at UCSF Clinical Trials.