Trials / Unknown
UnknownNCT01935843
Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors
Clinical Study of Chimeric HER-2 Antigen Receptor-modified T Cells in Chemotherapy Refractory HER-2 Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Conditions
- Advanced HER-2 Positive Solid Tumors
- Chemotherapy Refactory
- HER-2 Antibody Inhibitor Therapy Refactory
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CART-HER-2 |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-09-01
- Completion
- 2017-09-01
- First posted
- 2013-09-05
- Last updated
- 2016-01-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01935843. Inclusion in this directory is not an endorsement.