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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
NA trial testing TM4SF1-positive chimeric antigen receptor T-cell therapy in Digestive Tumor in 24 participants. Status unknown.
30 July 2024
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 30 January 2023 |
| Primary completion | 30 July 2024 |
| Estimated completion | 30 January 2025 |
Drugs / interventions tested
- TM4SF1-positive chimeric antigen receptor T-cell therapy — full drug profile →
Conditions studied
- Digestive Tumor — all drugs for Digestive Tumor →
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):
-
Immunotherapy in Gastrointestinal Cancers: Current Insights.
Jiang X, Zhan Y, Yang DH, Bao L. · · 2025 · cited 1× · PMID 40726819 · DOI 10.2147/cpaa.s497836 -
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
Verify or expand the search:
- PubMed search for NCT05673434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07507071 — Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions · not yet recruiting
- NCT07481591 — Capsule Endoscopy in GI Bleeding: A Retrospective Study · not yet recruiting
- NCT07439757 — AI-Powered Precision Decision-Making for Pancreatic Diseases · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05673434 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Changhai Hospital
- Last refreshed: 6 January 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing