Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Pancreatic Cancer
Conditions
Keywords
CEA, CAR T
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAnti-CEA-CAR T
T cells modified with CEA targeted chimeric antigen receptor.
Sponsors
Southwest Hospital, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Relapsed or refractory CEA positive lung cancer, pancreatic cancer, gastric cancer, breast cancer and colorectal cancer. 2. KPS\>60. 3. Life expectancy\>3 months. 4. Gender unlimited, age from 18 years to 80 years. 5. Disease progresses but reserves reaction to recent treatments. 6. Patients who have failed at least one line of a standard treatment. 7. No serious mental disorder. 8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L). 9. No other serious diseases(autoimmune disease, immunodeficiency etc.). 10. No other tumors. 11. Patients volunteer to participate in the research.
Exclusion criteria
1. KPS\<50. 2. Patients are allergic to cytokines. 3. MODS. 4. Uncontrolled active infection. 5. Acute or chronic GVHD. 6. Treated with T cell inhibitor. 7. Pregnancy and nursing females. 8. HIV affected. 9. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of each patient. | 3 years | Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time of Anti-CEA CAR T cells in vivo. | 3 years | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. |
| 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. | 4 weeks | To confirm the maximum tolerated dose of CEA targeted CAR T cells. |
Countries
China
Contacts
Primary ContactCheng Qian, MD, PhD
Backup ContactZhi Yang, PhD
Outcome results
None listed