CT041 CAR-T Therapy for Stomach and Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byHarry H Yoon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Carsgen Therapeutics, Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers

Eligibility Criteria

This trial is for adults aged 18-75 with advanced gastric or pancreatic cancer, who have tried other treatments without success. They must not be pregnant, have HIV/HBV/HCV, uncontrolled infections, significant heart/lung/neurological disorders, autoimmune diseases, a second cancer besides STAD/PAAD or previous cell therapies/transplants.

Inclusion Criteria

Your doctor thinks you will live for more than 4 months.

Voluntarily signed the ICF

My blood, kidney, and liver tests are within normal ranges.

See 9 more

Exclusion Criteria

I need blood-thinning medication like warfarin or heparin.

I have another type of cancer besides stomach or pancreatic cancer.

My cancer has significantly affected my lungs.

See 18 more

Treatment Details

Interventions

CT041 (CAR T-cell Therapy)

Trial OverviewThe study tests CT041 CAR-T cells targeting claudin18.2 in patients with specific digestive cancers. It's an early-phase trial to assess safety and effectiveness of this therapy in those whose tumors express CLDN18.2 and who've failed standard treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: anti-claudin18.2 chimeric antigen receptor T-cell therapyExperimental Treatment1 Intervention

Phase 1b will include two parts, dose escalation phase (Cohort A) followed by a dose expansion phase (Cohort B). Phase 2 (Cohort C) will evaluate the chosen dose in patients with advanced gastric cancer.