Multi-4SCAR-T Therapy Targeting Breast Cancer

Summary

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.

Eligibility

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.

Conditions2

Interventions1

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