Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors
NCT05415475 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2024-01-05
Summary
This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.
Conditions
- Colorectal Cancer
- Esophageal Cancer
- Stomach Cancer
- Pancreatic Cancer
- Metastatic Tumor
- Recurrent Cancer
Interventions
- BIOLOGICAL
-
CEA CAR-T cells
Administration method: intravenous infusion or intraperitoneal injection; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Sponsors & Collaborators
-
Chongqing Precision Biotech Co., Ltd
lead INDUSTRY
Principal Investigators
-
Jingwang Bi, M.D · Shandong Second Provincial General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-10
- Primary Completion
- 2024-09-15
- Completion
- 2025-09-15
Countries
- China
Study Locations
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