The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product. The main questions it aims to answer are: 1. What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion? 2. What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)? Participants will: 1. Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing. 2. May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed. 3. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. 4. Receive autologous CAR-T cells infusion on Day 0. 5. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 6. Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
injection of CAR T cells
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
the incidence rate of CAR-T-related adverse events
Time frame: up to 3 months after CAR-T injection
objective response rate (ORR)
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: up to 18 months
Progression-free survival (PFS)
Time frame: up to 18 months
Duration of response (DOR)
Time frame: up to 18 months
Overall Survival (OS)
Time frame: up to 18 months
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