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NCT05673434

A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1-positive Tumors of Digestive System

Status unknown NA Last updated 6 January 2023
What this trial tests

NA trial testing TM4SF1-positive chimeric antigen receptor T-cell therapy in Digestive Tumor in 24 participants. Status unknown.

Timeline
30 January 2023
Primary endpoint
30 July 2024
30 January 2025

Quick facts

Lead sponsorChanghai Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date30 January 2023
Primary completion30 July 2024
Estimated completion30 January 2025

Drugs / interventions tested

Conditions studied

Sponsor

Changhai Hospital

Who can join

Adults 18 to 75, any sex, with Digestive Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Transmembrane 4 L Six Family Member 1 (TM4SF1) is highly expressed in many tumors of digestive system . The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 has been generated in our good manufacturing practices (GMP) facility and the anti-tumor effects have been demonstrated in multiple in vitro and in vivo studies. Clinical studies are proposed here to evaluate the anti-tumor activity of these cell therapy products for treatment of patients with TM4SF1 positive tumors of digestive system. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 cells will be examined in patients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or liver cancer. Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in Gastrointestinal Cancers: Current Insights.
    Jiang X, Zhan Y, Yang DH, Bao L. · · 2025 · cited 1× · PMID 40726819 · DOI 10.2147/cpaa.s497836
  2. CAR-T cell therapy for pancreatic cancer: Translating emerging targets and dual-targeting strategies from solid tumors.
    Shen S, Ruan Z, Jiang B, Qiu W, et al · · 2026 · PMID 42039159 · DOI 10.3389/fimmu.2026.1764452

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Other Changhai Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05673434.

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