Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors
NCT05981235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-07-31
Summary
This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors.
Conditions
- Gastrointestinal Tumors
Interventions
- BIOLOGICAL
-
AZD6422 CLDN18.2 CAR-T product
AZD6422 CAR-T product infusion after pre-conditioning
Sponsors & Collaborators
- collaborator INDUSTRY
-
Peking University
lead OTHER
Principal Investigators
-
Lin Shen, PHD · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-14
- Primary Completion
- 2025-06-25
- Completion
- 2025-06-25
Countries
- China
Study Locations
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