Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors (CART-HER-2)
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|ClinicalTrials.gov Identifier: NCT01935843|
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : September 5, 2013
Last Update Posted : January 28, 2016
RATINALE: 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 HER-2 positive advanced solid tumors,such as breast cancer, gastric cancer, hepatic carcinoma, endometrial cancer and ovary cancer.
|Condition or disease||Intervention/treatment||Phase|
|Advanced HER-2 Positive Solid Tumors Chemotherapy Refactory HER-2 Antibody Inhibitor Therapy Refactory||Biological: CART-HER-2||Phase 1 Phase 2|
I.Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with anti-HER-2 vector(referred to as CART-HER-2 cells).
II.Determine duration of in vivo survival of CART-HER-2 cells. RT-PCR(reverse transcription polymerase chain reaction)analysis of whole blood will be used to detect and quantify survival of CART-HER-2 TCR zeta:CD137 and TCR(T-cell receptor) zeta cells over time.
I.For patients with detectable diseases, measure anti-tumor response due to CART-HER-2 cell infusions.
II.Estimate relative trafficking of CART-HER-2 cells in tumor bed.
III.Determine if cellular or humoral host immunity develops against the murine anti-HER-2, and assess correlation with loss of detectable CART-HER-2(loss of engraftment).
IV.Determine the relative subsets of CART-HER-2 T cells (Tcm,Tem,and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-HER-2-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 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-HER-2 cells in peripheral blood.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Chimeric HER-2 Antigen Receptor-modified T Cells in Chemotherapy Refractory HER-2 Advanced Solid Tumors|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2017|
|Experimental: Anti-tumor responses of CART-HER-2||
- Occurrence of Study related adverse events [ Time Frame: Until week 24 ]
- Anti-leukemia response to CART-HER-2 cell infusions [ Time Frame: up to 24 weeks ]
- In vivo existence of CART-HER-2 [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935843
|Contact: Weidong Han, Dr.||+email@example.com|
|Contact: Xiru Li, Dr.||+86-10-13910594988||Huyi0401@yahoo.com.cn|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, Dr. +86-10-13811421950 firstname.lastname@example.org|
|Principal Investigator: Yao Wang, Dr.|
|Study Chair:||Weidong Han, Dr.||Chinese PLA General Hospital|