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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.
Full 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.
II. Estimate relative trafficking of CART-EGFR cells in tumor bed.
III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR, and assess correlation with loss of detectable CART-EGFR (loss of engraftment).
IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling domains)Lentivirus vector-transduced autologous T cells for 3-5 days in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.
Estimate relative trafficking of CART-EGFR cells in peripheral blood.
Enrollment
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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 0-2.
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 criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
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Central trial contact
weidong han, Dr.; kaichao feng, Dr.
Data sourced from clinicaltrials.gov
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