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CAR-T for Claudin18.2 Positive Solid Tumors

NCT07266311 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Claudin18.2 Positive Advanced Solid Tumors

Interventions

DRUG

claudin18.2 CAR-T

injection of CAR T cells

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • Chengdu Ucello Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2035-12-31
Completion
2037-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266311 on ClinicalTrials.gov