A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors

Summary

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Timeline

Start

2022-05-25

Primary completion

2026-06-30

Completion

2026-06-30

Outcome

Met primary endpoint

paper The predefined safety endpoint was met. PMID 41760800 ↗

Publications

• Gao Y, Li J, Zhang H, Zhang Y, Qian S, Zhu X, Hong L, Xie L, Fu Q, Bao X, Tong Z, Li Y, Li B, Wang L, Shen J, Zhang Q, He X, Zheng Y, Yao C, Liu L, Zhao P, Campos PV, Yang Z, Qian C, Fang W. Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial. Nat Cancer. 2026 Apr;7(4):608-621. doi: 10.1038/s43018-026-01124-3. Epub 2026 Feb 27.
• Ye K, Yu C, Shen Z. Severe refractory colitis after intraperitoneal infusion of CEA-directed CAR T cells in patients with colorectal cancer. Ther Adv Med Oncol. 2024 Dec 23;16:17588359241309825. doi: 10.1177/17588359241309825. eCollection 2024.

Drugs

Indications