Clinical trial · Interventional
Multi-4SCAR-T Therapy Targeting Breast Cancer
Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer
NCT04430595CI-TRIAL-00123956not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4SCAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiple 4SCAR T cells to treat breast cancer
- description
- Multiple 4SCAR T cells to treat breast cancer
- interventionNames
- Biological: 4SCAR T cells
Primary outcomes (1)
- measure
- Number of patients with adverse events.
- timeFrame
- 3 year
- description
- Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0
Secondary outcomes (3)
- measure
- Anti-tumor effects
- timeFrame
- 3 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 75 years. 3. 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side effects of chemotherapy have subsided. 5. The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry. 6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 7. Expected survival ≥ 12 weeks. 8. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10\^6/L; platelet (PLT) ≥ 1×10\^8/L. 9. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST/ALT ≤ 2.5×ULN. 10. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 6. Inadequate liver and renal function with serum creatinine \> 1.5 mg/dl; serum (total) bilirubin \> 2.0 mg/dl; AST \& ALT \> 3 x ULN. 7. Pregnant or lactating females. 8. Serious active infection during screening. 9. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection. 10. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
References
Publications (0)
Data not yet available
No reference posted for this study.