A Clinical Research of CAR T Cells Targeting CEA Positive Cancer

Army Medical University

Status and phase: Unknown; Phase 1

Conditions: Breast Cancer; Gastric Cancer; Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Biological: Anti-CEA-CAR T

Study type: Interventional

Funder types: Other

Identifiers

NCT02349724

TMMU-BTC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 5 patient groups

Pancreatic cancer

Other group

Description:

Pancreatic cancer treated with Anti-CEA-CAR T.

Treatment:

Biological: Anti-CEA-CAR T

Lung cancer

Other group

Description:

Lung cancer treated with T cells modified with Anti-CEA-CAR T.

Treatment:

Biological: Anti-CEA-CAR T

Gastric cancer

Other group

Description:

Gastric cancer treated with T cells modified with Anti-CEA-CAR T.

Treatment:

Biological: Anti-CEA-CAR T

Breast cancer

Other group

Description:

Breast cancer treated with T cells modified with Anti-CEA-CAR T.

Treatment:

Biological: Anti-CEA-CAR T

Colorectal cancer

Other group

Description:

Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.

Treatment:

Biological: Anti-CEA-CAR T