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| Name | Class |
|---|---|
| HuaDao (Shanghai) Biomedical Co., Ltd. | OTHER |
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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 few studies 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. 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 |
|---|---|---|---|
| Colorectal cancer | Experimental | 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 that related to treatment | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) | 4 weeks |
| 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 months |
| 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 | |
|---|---|---|---|---|
| Mei Wang, Medical PhD | Contact | +86-13601810867 | 13601810867@163.com | |
| Lin Tian, Medical PhD | Contact | 13651760950 | lin.tian@huadaocart.com |
| Name | Affiliation | Role |
|---|---|---|
| Ren Zhao, Medical PhD | Ruijin Hospital | Principal Investigator |
| Mei Wang, Medical PhD | Ruijin Hospital | Principal Investigator |
| Chen xianze, Medical PhD |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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To evaluate the presence of circulating tumor cells with flow cytometry and real time PCR in patient blood. |
| 6 months |
| Maximum tolerated dose (MTD) of CEA targeted CAR T cells | To confirm the maximum tolerated dose of CEA targeted CAR T cells. | 4 weeks |
| Ruijin Hospital |
| Study Chair |
| Liu Kun, Medical PhD | Ruijin Hospital | Study Chair |
| Shi Yiqing, Medical PhD | Ruijin Hospital | Study Chair |
| Wang Chen, Medical PhD | Ruijin Hospital | Study Chair |
| He Qianyun, Medical PhD | Ruijin Hospital | Study Chair |
| Mao Dongliang, Medical PhD | Ruijin Hospital | Study Chair |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |