A Phase 1/2 interventional study of CART-HER-2 in Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory and HER-2 Antibody Inhibitor Therapy Refactory, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
Exclusion Criteria:
Biological: 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
This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital