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NOT YET RECRUITING
NCT07553793
PHASE1

Chimeric Antigen Receptor Macrophages Targeting c-MET for Advanced Stage of Pancreatic Cancer Patients

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

Chemotherapy is the first-line treatment for advanced-stage pancreatic cancer patients. However, drug resistance always occurs within 6 months. For these patients, no effective treatment is available. Chimeric antigen receptor macrophage targeting C-MET( CAR-M-C-MET) is a novel cellular therapy for these patients. In this clinical trial, advanced-stage pancreatic cancer patients when tumor progression after chemotherapy are enrolled to test the safety and anti-tumor efficacy of this novel cellular therapy.

Official title: Human Chimeric Antigen Receptor Macrophages Targeting C-MET for C-MET-positive Advanced Stage of Pancreatic Cancer Patients: A Single-arm, Single-center, IIT Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-05-01

Completion Date

2029-12-01

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

CAR-M-C-MET cell intraperitoneal infusion

Enroll 3 subjects in the 2×10⁸ (Dose-1) cohort, followed by enrollment in the 4.0×10⁸ (Dose-2) cohort. If 1 subject experiences a dose limited toxicity (DLT) during observation period (4 weeks), enroll an additional 3 subjects. If ≥2 subjects experience a DLT after cell reinfusion in the initial 3 subjects of the Dose-1 cohort, the trial will be paused, and the investigator and the Data Monitoring Committee (DMC) will discuss dose reduction or protocol adjustment.For the Dose-2 cohort, initially enroll 3 subjects. If 1 subject experiences a DLT, enroll an additional 3 subjects. If DLTs ≤1, escalate to 1.0×10⁹ (Dose-3). For Dose-n (n=1,2,3), if the DLT proportion is ≥2/6 subjects, then Dose-n-1 will be designated as the RPD2. If no more than 2 DLT events occur in the Dose-3 cohort, then Dose-3 will be designated as the RPD2. For the first three subjects in each dose cohort, cell reinfusion for the next subject can only proceed after the previous subject has completed

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China