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An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors

StatusUnknown
PhasePhase 1
Started2023-10-23
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 21, 2024 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-02-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Unknown
Start dateestimated 2023-09-01→confirmed 2023-10-23
Study sites0→1
2023-08-22
minor
Original filing
This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Trial Details
NCT Number NCT06013111
Lead Sponsor China Medical University, China
Collaborators: Shanghai First Song Therapeutics Co., Ltd
Conditions Carcinoma
Enrollment 9 participants
Start Date 2023-10-23
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-02-21