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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic cancer | Other | Pancreatic cancer treated with Anti-CEA-CAR T. |
|
| Lung cancer | Other | Lung cancer treated with T cells modified with Anti-CEA-CAR T. |
|
| Gastric cancer | Other | Gastric cancer treated with T cells modified with Anti-CEA-CAR T. |
|
| Breast cancer | Other | Breast cancer treated with T cells modified with Anti-CEA-CAR T. |
|
| Colorectal cancer | Other | Colorectal cancer treated with T cells modified with Anti-CEA-CAR T. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CEA-CAR T | Biological | T cells modified with CEA targeted chimeric antigen receptor. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Qian, MD, PhD | Contact | 0086-023-68765461 | cqian8634@gmail.com | |
| Zhi Yang, PhD | Contact | 0086-13206140093 | Lystch@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Qian, MD, PhD | Southwest Hospital, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital of Third Millitary Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |