Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced HER-2 Positive Solid Tumors | — | UNRESOLVED | — |
| Chemotherapy Refactory | — | UNRESOLVED | — |
| HER-2 Antibody Inhibitor Therapy Refactory | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-HER-2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-tumor responses of CART-HER-2
- interventionNames
- Biological: CART-HER-2
Primary outcomes (1)
- measure
- Occurrence of Study related adverse events
- timeFrame
- Until week 24
Secondary outcomes (1)
- measure
- Anti-leukemia response to CART-HER-2 cell infusions
- timeFrame
- up to 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Chemotherapy refractory HER-2-positive breast cancer, gastric cancer, non-small cell lung cancer, and chemotherapy resistant or relapsed ovary cancer. * Relapsed patients after anti-HER-2 using antibody or kinase inhibitor therapy. * Patients must be 18 years of age or older. * Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2. * Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters: 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). * Seronegative for HIV antibody. * Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. * Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test. * Patients must be willing to sign an informed consent. Exclusion Criteria: * Patients with life expectancy less than 12 months will be excluded. * Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded. * Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air. * Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded. * Pregnant and/or lactating women will be excluded. * Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors. * Patients with any type of primary immunodeficiencies will be excluded from the study. * Patients requiring corticosteroids (other than inhaled) will be excluded. * Patients with history of T cell tumors will be excluded. * Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
References
Publications (1)
- DERIVEDFeng K, Liu Y, Guo Y, Qiu J, Wu Z, Dai H, Yang Q, Wang Y, Han W. Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers. Protein Cell. 2018 Oct;9(10):838-847. doi: 10.1007/s13238-017-0440-4. Epub 2017 Jul 14. PMID 28710747