Trials / Recruiting
RecruitingNCT06126406
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Chongqing Precision Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
According to the infusion ways, it is divided into two subgroups: intravenous infusion and intraperitoneal injection. Each subgroup includes a dose exploration stage and a dose expansion stage. 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.
Conditions
- Gastric Cancer
- Colon Cancer
- Rectal Cancer
- Breast Cancer
- Lung Cancer
- Esophagus Cancer
- Cholangiocarcinoma
- Pancreas Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CEA-targeted CAR-T cells | Administration method: intravenous infusion Subjects will receive conditioning therapy by ludarabine and Cyclophosphamide before cell infusion. |
| BIOLOGICAL | CEA-targeted CAR-T cells | Administration method: intraperitoneal injection Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion. |
Timeline
- Start date
- 2023-11-06
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2023-11-13
- Last updated
- 2023-11-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06126406. Inclusion in this directory is not an endorsement.