Claudin18.2 CAR-T (CT041) in Patients With Gastric or Pancreatic Cancer

Titre officiel

Open-label, Multicentre, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous Claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma

Sommaire:

A Phase 1b, open label, multi-centre, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic adenocarcinoma

Description de l'essai

Primary Outcome:

• Incidence of Treatment Related adverse events (AEs)
• Identification of Maximum Tolerated Dose (MTD)

Secondary Outcome:

• Time to Progression
• Duration of Response
• Disease Control Rate
• Progression free survival
• Overall survival

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

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, patients must have tumour 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.

Voir cet essai sur ClinicalTrials.gov