Phase 1 Trial: Evaluating Claudin18.2-Specific CAR T Cells in Gastrointestinal Cancers

Apart from hematologic malignancies, treatments revolving CAR T therapy for solid tumors remain limited. A preclinical study is being conducted redirecting CAR T cells in gastric cancers, showing promising efficacy.

This phase 1 clinical trial evaluates the safety and effectiveness of CLDN18.2-targeted CAR-T cells (CT041) in patients with previously treated, CLDN18.2-positive digestive system cancers. The primary objective of this study is to evaluate the safety after CT041 infusion, as well as included CT041 efficacy, pharmacokinetics, and immunogenicity in patients with advanced gastric, pancreatic, or other digestive system cancers.

The study included 37 cohorts with one of three CT041 doses: 2.5 × 108, 3.75 × 108 or 5.0 × 108 cells. All patients experienced a grade 3 or higher hematologic toxicity. 94.6% of patients experienced Grade 1 or 2 cytokine release syndrome (CRS). There was no grade 3 or higher CRS or neurotoxicities, treatment-related deaths or dose-limiting toxicities were reported. The overall response rate (ORR) reached 48.6% and the disease control rate (DCR) reached 73%, respectively. The 6-month duration of response rate presented at 44.8%. In patients with gastric cancers, the ORR reached 57.1% and DCR reached 75.0% respectively, with a 6-month overall survival rate of 81.2%.  

The conclusion of these results suggests that CT041 has promising efficacy with an acceptable safety profile in patients with heavily pretreated, CLDN18.2-positive digestive system cancers, particularly in those with gastrointestinal cancers.

This trial is currently accepting eligible patients.

If you'd like to refer a patient to Moffitt Cancer Center, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.