Multi-4SCAR-T Therapy Targeting Breast Cancer
Recruiting · NCT04430595 · Interventional (participants receive a specific treatment) · Lead sponsor: Shenzhen Geno-Immune Medical Institute
View the official record on ClinicalTrials.gov →Interventions studied
4SCAR T cells
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.
- Age: ≥ 18 years and ≤ 75 years.
- 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
- Side effects of chemotherapy have subsided.
- The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry.
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
- Expected survival ≥ 12 weeks.
- Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10\^6/L; platelet (PLT) ≥ 1×10\^8/L.
- 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.
- Oxygen saturation ≥ 90%.
- Written, informed consent obtained prior to any study-specific procedures.
Exclusion criteria
- Airway obstruction caused by tumor.
- History of epilepsy or other central nervous system diseases.
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- History of prolonged or serious heart disease during QT.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
- Inadequate liver and renal function with serum creatinine \> 1.5 mg/dl; serum (total) bilirubin \> 2.0 mg/dl; AST \& ALT \> 3 x ULN.
- Pregnant or lactating females.
- Serious active infection during screening.
- Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Where it is running
1 location listed.
- Shenzhen Geno-immuno Medical Institute - Shenzhen, Guangdong, China