Status:
UNKNOWN
Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
T Lymphoblastic Leukemia/Lymphoma
Mixed Phenotype Acute Leukemia
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients...
Detailed Description
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
Eligibility Criteria
Inclusion
- Diagnosed CD7 positive relapsed/refractory acute leukemia.
- Age 12-65 years.
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
- CD7 on leukemia is \>30% positive detected with flow cytometry.
- Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
Exclusion
- Patients are pregnant or lactating
- Patients with congenital immunodeficiency.
- Patients with central nervous system leukemia.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
- Patients with atrial or venous thrombosis or embolism.
- Patients with myo-infarction or severe arrythmia in the recent 6 months.
- Other comorbidities that investigators considered not suitable for this study.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04762485
Start Date
June 1 2021
End Date
February 28 2024
Last Update
June 2 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, (Select), China, 215000