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 ]
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): NCT01935843
|Contact: Weidong Han, Dr.||+firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Yao Wang, Dr.|
|Study Chair:||Weidong Han, Dr.||Chinese PLA General Hospital|