Clinical trialPhase 1 / Phase 2Completed
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
Chimeric Antigen Receptor T Lymphocytes (CAR-T) Targeting CEA in the Treatment of CEA Positive Clinical Study of Advanced Malignant Solid Tumors
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 7 June 2022
- Ended
- 7 February 2024
- Enrollment
- 17 participants
- Sites
- 1
- Primary outcomes
- To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]; Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies[Safety and Tolerability]
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 10 July 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Detailed description public domain (ClinicalTrials.gov)
According to the different infusion methods, it is divided into two subgroups: intravenous infusion and local infusion through the peritoneal cavity. Each subgroup includes a dose exploration stage (Part A) and a dose expansion stage (Part B). 3 patients were explored, starting from the low-dose group, and in the dose expansion phase, the safety and efficacy were further verified according to the safe recommended dose obtained in the dose exploration phase.