Pancreatic Cancer Research

Clinical trialPhase 1 / Phase 2Unknown

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

NCT01869166↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
Phase 1 / Phase 2
Status
Unknown
Study type
Interventional
Start
May 2013
Listed end
December 2017
Enrollment
60 participants
Sites
1
Primary outcomes
Occurrence of study related adverse events
Sponsor type
Academic / other
Results posted
No
Last update
29 September 2015

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Papers 3