Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

Conditions
T Cell LymphomaT-cell Leukemia
Interventions
BIOLOGICAL

chimeric antigen receptor T cell treatment

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.

Trial Locations (1)

100000

Beijing Boren Hospital, Beijing

All Listed Sponsors
lead

Beijing Boren Hospital

OTHER

NCT04840875 - Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma | Biotech Hunter | Biotech Hunter