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Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
Age
0 - 70 years
Sex
ALL
Healthy Volunteers
No
Beijing Boren Hospital
Beijing, Beijing Municipality, China
Start Date
September 14, 2021
Primary Completion Date
September 1, 2023
Completion Date
September 1, 2023
Last Updated
November 14, 2024
16
ACTUAL participants
chimeric antigen receptor T cell treatment
BIOLOGICAL
Lead Sponsor
Beijing Boren Hospital
NCT07388563
NCT06698003
Data Source & Attribution
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