NCT06126406

Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors

Recruiting now Phase 1 Last updated 13 November 2023

What this trial tests

Phase 1 trial testing CEA-targeted CAR-T cells in Gastric Cancer in 60 participants. Currently enrolling.

Timeline

6 November 2023

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	Chongqing Precision Biotech Co., Ltd
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	6 November 2023
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• CEA-targeted CAR-T cells — full drug profile →
• CEA-targeted CAR-T cells — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Colon Cancer — all drugs for Colon Cancer →
• Rectal Cancer — all drugs for Rectal Cancer →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Chongqing Precision Biotech Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Gastric Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

Publications & conference data

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

1. Current and future immunotherapy for breast cancer.
   Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
2. Advances in CAR T cell therapy: antigen selection, modifications, and current trials for solid tumors.
   Khan SH, Choi Y, Veena M, Lee JK, et al · · 2024 · cited 27× · PMID 39835140 · DOI 10.3389/fimmu.2024.1489827
3. Current and Emerging Treatment Options for Pancreatic Cancer: A Comprehensive Review.
   Hayat U, Croce PS, Saadeh A, Desai K, et al · · 2025 · cited 17× · PMID 40004658 · DOI 10.3390/jcm14041129
4. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6
5. Prospects of Synergy: Local Interventions and CAR T Cell Therapy in Solid Tumors.
   Holtermann A, Gislon M, Angele M, Subklewe M, et al · · 2024 · cited 13× · PMID 39080180 · DOI 10.1007/s40259-024-00669-y
6. Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
   Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543
7. Expanding the Horizons of CAR-T Cell Therapy: A Review of Therapeutic Targets Across Diverse Diseases.
   Hernández-López A, Olaya-Vargas A, Bustamante-Ogando JC, Meneses-Acosta A. · · 2025 · cited 10× · PMID 40005970 · DOI 10.3390/ph18020156
8. Molecular Mechanism for Malignant Progression of Gastric Cancer Within the Tumor Microenvironment.
   Matsuoka T, Yashiro M. · · 2024 · cited 9× · PMID 39519285 · DOI 10.3390/ijms252111735