RecruitingPhase 1NCT05911217

A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

Sponsor

CARsgen Therapeutics Co., Ltd.

Enrollment

20 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

Summary

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy (CT041) — where your own immune cells are reprogrammed to fight cancer — as a follow-up treatment after surgery for pancreatic cancer. **You may be eligible if...** - You are 18–79 years old - You have had your pancreatic cancer surgically removed - Your cancer tests positive for a protein called CLDN18.2 - You completed 3 months of standard chemotherapy after surgery - Your CA19-9 blood marker is still abnormal - You have good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread or come back - You had pre-surgery chemotherapy - You are pregnant, breastfeeding, or HIV/hepatitis positive - You have active infections or serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCT041 autologous CAR T-cell injection

Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion

Locations(8)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology

Wuhan, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05911217

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