A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors
NCT07409766 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-13
Summary
This is a single-arm, open-label, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting various antigens (including HER2, PSMA, FAP, etc.) in patients with advanced solid tumors. The clinical trial is designed to be conducted in cohorts, with patients enrolled into respective cohorts based on target antigen and indication screening
Conditions
- Advanced Malignant Tumors
Interventions
- BIOLOGICAL
-
CAR-M
IV
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Principal Investigators
-
Ning Li, Dr · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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