NCT04762485
Unknown
Phase 1
Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
The First Affiliated Hospital of Soochow University1 site in 1 country20 target enrollmentJune 1, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Sponsor
- The First Affiliated Hospital of Soochow University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events
- Last Updated
- 4 years ago
Overview
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 with refractory/relapsed CD7 positive acute leukemia.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed CD7 positive relapsed/refractory acute leukemia.
- •Age 12-65 years.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Number of Adverse Events
Time Frame: 12 months
Adverse events are evaluated with CTCAE V5.0
Secondary Outcomes
- the duration of CAR T-cells in vivo(2 years)
- Overall response rate (ORR)(2 years)
- Cumulative incidence of relapse(CIR)(2 years)
Study Sites (1)
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