Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Active not recruiting

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer

NCT04581473↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Ongoing
Phase
Phase 1 / Phase 2
Status
Active not recruiting
Study type
Interventional
Start
23 October 2020
Expected end
30 June 2038
Enrollment
192 participants
Sites
24
Primary outcomes
Phase Ib: Incidence of Treatment Related adverse events (AEs); Phase Ib: Identification of Maximum Tolerated Dose (MTD); Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice
Sponsor
Industry
Results posted
No
Last update
5 June 2025

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Brief summary public domain (ClinicalTrials.gov)

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

Detailed description public domain (ClinicalTrials.gov)

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

Papers 3