Clinical trial NCT02349724: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lung Cancer
Colorectal Cancer
Gastric Cancer
Breast Cancer
Pancreatic Cancer
Keywords: CEA
CAR T
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse events of each patient.
timeFrame: 3 years
Secondary outcomes:
measure: Survival time of Anti-CEA CAR T cells in vivo.
timeFrame: 3 years
measure: Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells
timeFrame: 12 weeks
measure: Maximum tolerated dose (MTD) of CEA targeted CAR T cells.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of Third Millitary Medical University
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Cheng Qian, MD, PhD
role: STUDY_CHAIR
References: