Clinical trialPhase 1Unknown
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
- Outcome
- Outcome unknown
- Cell product
- CAR-T cells
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
- Target antigen
- CEA
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- December 2014
- Listed end
- December 2019
- Enrollment
- 75 participants
- Sites
- 1
- Primary outcomes
- Adverse events of each patient.
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 25 April 2017
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Biological: Anti-CEA-CAR T. T cells modified with CEA targeted chimeric antigen receptor.
Arm public domain (ClinicalTrials.gov)
Pancreatic cancer (other): Pancreatic cancer treated with Anti-CEA-CAR T.
Arm public domain (ClinicalTrials.gov)
Lung cancer (other): Lung cancer treated with T cells modified with Anti-CEA-CAR T.
Arm public domain (ClinicalTrials.gov)
Gastric cancer (other): Gastric cancer treated with T cells modified with Anti-CEA-CAR T.
Arm public domain (ClinicalTrials.gov)
Breast cancer (other): Breast cancer treated with T cells modified with Anti-CEA-CAR T.
Arm public domain (ClinicalTrials.gov)
Colorectal cancer (other): Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.
Eligibility public domain (ClinicalTrials.gov)
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.