Chimeric Antigen Receptor Macrophages Targeting c-MET for Advanced Stage of Pancreatic Cancer Patients
NCT07553793 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-04-28
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.
Conditions
- Pancreatic Cancer
- Advanced Stage Cancer
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
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Quan Liao, MD · Peking Union Medical College Hospital
-
Wenming Wu, MD · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2028-12-01
- Completion
- 2029-12-01
Countries
- China
Study Locations
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