NCT01869166UnknownPhase 1
Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors
Chinese PLA General Hospital1 site in 1 country60 target enrollmentStarted: May 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Occurrence of study related adverse events
Study Overview
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: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with EGFR positive advanced/unresectable operation solid tumors, such as lung cancer, colorectal cancer，ovary cancer，cholangiocarcinoma，pancreatic cancer，renal carcinoma and other relapsed/metastatic tumors.
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 duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-EGFR CD3zeta:CD137 over time.
SECONDARY OBJECTIVES:
I. For patients with advanced， relapsed/metastatic cancers, measure anti-tumor response due to CART-EGFR cell infusions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters:
- •Absolute neutrophil count greater than 1500/mm
- •Platelet count greater than 100,000/mm
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Occurrence of study related adverse events
Time Frame: Until week 24
Secondary Outcomes
- Anti-tumor responses to CART-EGFR cell infusions(up to 24 weeks)
Investigators
Han weidong
Professor and Director
Chinese PLA General Hospital
Study Sites (1)
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