Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.
NCT03874897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2024-04-30
Summary
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
CAR-CLDN18.2 T-Cells
Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses • Chimeric Antigen Receptor T Cells Targeting Claudin18.2
- DRUG
-
PD-1 Monoclonal Antibody
Chimeric Antigen Receptor T Cells Targeting Claudin18.2 with PD-1
- DRUG
-
First-line systemic therapy according to physician's choice
Sponsors & Collaborators
-
CARsgen Therapeutics Co., Ltd.
collaborator INDUSTRY -
Peking University
lead OTHER
Principal Investigators
-
Lin Shen · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-26
- Primary Completion
- 2021-03-20
- Completion
- 2024-01-26
Countries
- China
Study Locations
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