- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2014-12
2018-12
2019-12
75
NCT02349724
Southwest Hospital, China
Southwest Hospital, China
INTERVENTIONAL
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has not yet been fully explored in solid tumors. The carcino-embryonic antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
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 |
|---|---|---|
2015-01-25 | N/A | 2017-04-24 |
2015-01-28 | N/A | 2017-04-25 |
2015-01-29 | N/A | 2016-03 |
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:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Pancreatic cancer Pancreatic cancer treated with Anti-CEA-CAR T. | BIOLOGICAL: Anti-CEA-CAR T
|
| OTHER: Lung cancer Lung cancer treated with T cells modified with Anti-CEA-CAR T. | BIOLOGICAL: Anti-CEA-CAR T
|
| OTHER: Gastric cancer Gastric cancer treated with T cells modified with Anti-CEA-CAR T. | BIOLOGICAL: Anti-CEA-CAR T
|
| OTHER: Breast cancer Breast cancer treated with T cells modified with Anti-CEA-CAR T. | BIOLOGICAL: Anti-CEA-CAR T
|
| OTHER: Colorectal cancer Colorectal cancer treated with T cells modified with Anti-CEA-CAR T. | BIOLOGICAL: Anti-CEA-CAR T
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adverse events of each patient. | Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Survival time of Anti-CEA CAR T cells in vivo. | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. | 3 years |
| Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells | 12 weeks | |
| Maximum tolerated dose (MTD) of CEA targeted CAR T cells. | To confirm the maximum tolerated dose of CEA targeted CAR T cells. | 4 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Cheng Qian, MD, PhD Phone Number: 0086-023-68765461 Email: cqian8634@gmail.com |
Study Contact Backup Name: Zhi Yang, PhD Phone Number: 0086-13206140093 Email: Lystch@outlook.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
