Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT01869166
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.
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.
Study:
NCT01869166
Study Brief:
Protocol Section:
NCT01869166