NCT01869166

Treatment of Chemotherapy Refractory EGFR(Epidermal Growth Factor Receptor) Positive Advanced Solid Tumors (CART-EGFR)

Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced EGFR-positive Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	CART-EGFR

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2013-06-05
• Last updated: 2015-09-29

Locations

1 site across 1 country: China