Description:
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.
Title
- Brief Title: A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
- Official Title: A Clinical Research of Chimeric Antigen Receptor(CAR) T Cells Targeting CEA Positive Cancer
Clinical Trial IDs
- ORG STUDY ID:
TMMU-BTC-002
- NCT ID:
NCT02349724
Conditions
- Lung Cancer
- Colorectal Cancer
- Gastric Cancer
- Breast Cancer
- Pancreatic Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Anti-CEA-CAR T | | Breast cancer |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
Eligibility Criteria
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.
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Adverse events of each patient. |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | Determine the toxicity profile of the CEA targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. |
Secondary Outcome Measures
| Measure: | Survival time of Anti-CEA CAR T cells in vivo. |
| Time Frame: | 3 years |
| Safety Issue: | |
| Description: | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. |
| Measure: | Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells |
| Time Frame: | 12 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum tolerated dose (MTD) of CEA targeted CAR T cells. |
| Time Frame: | 4 weeks |
| Safety Issue: | |
| Description: | To confirm the maximum tolerated dose of CEA targeted CAR T cells. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Southwest Hospital, China |
Trial Keywords
Last Updated
April 25, 2017
