NCT05472857

Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression

Clinical Study of CLDN18.2-targeting Chimeric Antigen Receptor-modified Autologous T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression

Detailed description

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 (IMC002). Following manufacture of the drug product, subjects will receive preconditioning prior to IMC002 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Conditions

• Gastric Cancer
• Pancreatic Cancer
• Advanced Ovarian Carcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Claudin 18.2 CAR-T	treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion

Timeline

• Start date: 2022-08-08
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-07-25
• Last updated: 2024-03-06

Locations

1 site across 1 country: China