Status:
UNKNOWN
Multi-4SCAR-T Therapy Targeting Breast Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
The Seventh Affiliated Hospital of Sun Yat-sen University
Conditions:
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Breast cancer is one of the most frequent cancer types in women. The average risk of a woman in the United States developing breast cancer in her life is about 13%. That means that there is a 1 in 8 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04430595
Start Date
June 1 2020
End Date
December 31 2023
Last Update
June 12 2020
Active Locations (1)
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1
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107