Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
NCT06010862 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-11-08
Summary
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Conditions
- Gastric Cancer
- Colon Cancer
- Pancreas Cancer
- Esophagus Cancer
- Cholangiocarcinoma
- Lung Cancer
- Breast Cancer
Interventions
- BIOLOGICAL
-
CEA CAR-T cells
After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
- BIOLOGICAL
-
CEA CAR-T cells
After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally
Sponsors & Collaborators
-
The First Affiliated Hospital of Nanchang University
collaborator OTHER -
Chongqing Precision Biotech Co., Ltd
lead INDUSTRY
Principal Investigators
-
Fei Li, M.D · The First Affiliated Hospital of Nanchang University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-30
- Primary Completion
- 2025-12-31
- Completion
- 2026-09-30
Countries
- China
Study Locations
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