30
Participants
Start Date
September 6, 2023
Primary Completion Date
September 1, 2025
Study Completion Date
September 1, 2026
TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T cell (ATHENA CAR-T)
"Phase 1 dose escalation (3+3) : dose 1 (1 × 10\^6 cells/kg) , dose 2 (3 × 10\^6 cells/kg), dose 3 (1 × 10\^7 cells/kg); Phase 2 : dose of RP2D.~No more than 2 × 10\^5 per kilogram of allogenic residual CD3+T cells harbouring in grafts can only be released for recipient infusion."
Fludarabine
Intravenous fludarabine 30\~50 mg/m\^2/day on days -5, -4, and -3.
Cyclophosphamide
Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.
RECRUITING
Biotherapeutic Department, Chinese PLA General Hospital, Beijing
RECRUITING
EdiGene Inc, Beijing
RECRUITING
School of Life Sciences, Peking University, Beijing
Peking University
OTHER
EdiGene Inc.
INDUSTRY
Chinese PLA General Hospital
OTHER