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2023-09-30
2025-12-31
2026-09-30
36
NCT06010862
Chongqing Precision Biotech Co., Ltd
Chongqing Precision Biotech Co., Ltd
INTERVENTIONAL
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CEA-positive advanced/metastatic solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-08-18 | N/A | 2023-11-06 |
2023-08-23 | N/A | 2023-11-08 |
2023-08-25 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intravenous of CEA-targeted CAR-T Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg | BIOLOGICAL: CEA CAR-T cells
|
| EXPERIMENTAL: intraperitoneal injection of CEA-targeted CAR-T Infusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg | BIOLOGICAL: CEA CAR-T cells
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability] | Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) | 28 days |
| Obtain the maximum tolerated dose of CEA CAR-T cells[Safety and Tolerability] | Dose-limiting toxicity after cell infusion | 28 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease control rate of CAR-T cell preparations in CEA positive advanced malignancies [Effectiveness] | Disease control rate: The proportion of subjects who achieved CR, PR, SD after treatment accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome. | 3 months |
| Objective response rate (ORR) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness] | Objective response rate includes：The proportion of subjects who achieved CR, PR after treatment accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome. | 3 months |
| Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness] | DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause | 3 months |
| Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness] | OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause (Assessed based on RECIST criteria) | 2 years |
| Progress-free survival(PFS) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness] | PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria) | 2 years |
| AUCS of CEA CAR-T cells [Cell dynamics] | AUCS is defined as the area under the curve in 90 days | 3 months |
| CMAX of CEA CAR-T cells [Cell dynamics] | CMAX is defined as the highest concentration of CEA CAR-T cells expanded in | 3 months |
| TMAX of CEA CAR-T cells[Cell dynamics] | TMAX is defined as the time to reach the highest concentration | 3 months |
| Pharmacodynamics of CEA CAR-T cells[Cell dynamics] | Concentration levels of CAR-T-related serum cytokines such as CRP, IL-6, ferritin at each time point | 3 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Fei Li, M.D Phone Number: 13970038386 Email: 691058841@qq.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
