A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
NCT06043466 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-09-21
Summary
This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.
Conditions
- Colorectal Cancer
- Esophagus Cancer
- Gastric Cancer
- Pancreas Cancer
- Non-small Cell Lung Cancer
- Breast Cancer
- Bile Duct Cancer
Interventions
- BIOLOGICAL
-
CEA-targeted CAR-T cells
Administration method: intravenous infusion; Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
Sponsors & Collaborators
-
Zhejiang University
collaborator OTHER -
Chongqing Precision Biotech Co., Ltd
lead INDUSTRY
Principal Investigators
-
Ying Yuan, M.D · Second Affiliated Hospital, School of Medicine, Zhejiang University
-
Weijia Fang, M.D · Zhejiang University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-11
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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