Treatment of Chemotherapy Refractory EGFR(Epidermal Growth Factor Receptor) Positive Advanced Solid Tumors (CART-EGFR) (CART-EGFR)
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|ClinicalTrials.gov Identifier: NCT01869166|
Recruitment Status : Unknown
Verified September 2015 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : June 5, 2013
Last Update Posted : September 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced EGFR-positive Solid Tumors||Biological: CART-EGFR||Phase 1 Phase 2|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
|Experimental: anti-tumor response of CART-EGFR||
- Occurrence of study related adverse events [ Time Frame: Until week 24 ]
- Anti-tumor responses to CART-EGFR cell infusions [ Time Frame: up to 24 weeks ]
- in vivo existence of CART-EGFR [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869166
|Contact: weidong han, Dr.||email@example.com|
|Contact: kaichao feng, Dr.||firstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: weidong han, Dr. 86-10-13651392893 email@example.com|
|Contact: Kaichao Feng, Dr. 86-10-13811421950 firstname.lastname@example.org|
|Principal Investigator: Yao Wang, Dr.|
|Study Chair:||weidong han, Dr.||Chinese PLA General Hospital|