Status:
UNKNOWN
Treatment of Chemotherapy Refractory EGFR(Epidermal Growth Factor Receptor) Positive Advanced Solid Tumors (CART-EGFR)
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Advanced EGFR-positive Solid Tumors
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells. PURPOSE: Thi...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-EGFR Lentivirus vector (referred to as CART-EGFR cells). II. Determine d...
Eligibility Criteria
Inclusion
- Chemotherapy refractory EGFR-positive non-small cell lung cancer, colorectal cancer with liver metastasis,and chemotherapy resistant or relapsed ovary cancerlung cancer,cholangiocarcinoma，pancreatic cancer，renal carcinoma and other relapsed/metastatic/unresectable operation tumors.the expression of EGFR in tumor is more than 50%.
- Relapsed patients after anti-EGFR using antibody or kinase inhibitor therapy.
- Patients must be 18 years of age or older.
- Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
- Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters:
- Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
- Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
- Seronegative for HIV antibody.
- Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
- Patients must be willing to sign an informed consent.
Exclusion
- Patients with life expectancy less than 12 months will be excluded.
- Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- Pregnant and/or lactating women will be excluded.
- Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- Patients with any type of primary immunodeficiencies will be excluded from the study.
- Patients requiring corticosteroids (other than inhaled) will be excluded.
- Patients with history of T cell tumors will be excluded.
- Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01869166
Start Date
May 1 2013
End Date
December 1 2017
Last Update
September 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853