Clinical trial · Interventional
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reform CAR structure due to safety consideration
Summary
Brief summary (as posted)
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-HER2 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HER2 positive cancers
- description
- Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
- interventionNames
- Biological: Anti-HER2 CAR-T
Primary outcomes (1)
- measure
- Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- timeFrame
- 3 years
- description
- Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Secondary outcomes (3)
- measure
- Survival time of Anti-HER2 CAR T cells in vivo.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed or refractory HER2 positive cancer. 2. KPS\>60. 3. Life expectancy\>3 months. 4. Gender unlimited, age from 18 years to 80 years. 5. Assessable lesions with a minimum size of 10mm by CT scan or MRI. 6. Acceptable organ function Hematology: * Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim. * White blood cell (WBC) (\> 2000/mm\^3). * Platelet count greater than 50,000/mm\^3. * Hemoglobin greater than 9.0 g/dl. Chemistry: * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis). * Serum creatinine less or equal to 3 times the upper limit of normal * Total bilirubin less than or equal to 3 times the upper limit of normal. 7. No other serious diseases(autoimmune disease, immunodeficiency etc.). 8. Adequate cardiac function(LVEF≥40%). 9. No other tumors. 10. Patients volunteer to participate in the research. Exclusion Criteria: 1. Allergic to cytokines. 2. Uncontrolled active infection. 3. Acute or chronic GVHD. 4. MODS. 5. Treated with T cell inhibitor. 6. HIV affected. 7. Other situations improper for the research.
References
Publications (0)
Data not yet available