TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-ALL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 15, 2025

Primary Completion Date

February 15, 2027

Study Completion Date

February 15, 2028

Conditions
Acute Lymphocytic Leukemia
Interventions
BIOLOGICAL

TCR reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T cell

Phase 1 dose escalation (3+3) : dose 1 (1 × 10\^6 cells/kg) , dose 2 (3 × 10\^6 cells/kg), dose 3 (6 × 10\^6 cells/kg); Phase 2 : dose of RP2D.

DRUG

Fludarabine

Intravenous fludarabine 30\~50 mg/m\^2/day on days -5, -4, and -3.

DRUG

Cyclophosphamide

Intravenous cyclophosphamide 500\~1000 mg/m\^2/day on days -5, -4, and -3.

Trial Locations (3)

100853

RECRUITING

Biotherapeutic Department of Chinese PLA General Hospital, Beijing

Unknown

NOT_YET_RECRUITING

Department of Hematology, Peking Union Medical College Hospital, Beijing

NOT_YET_RECRUITING

Department of Hematology, Tianjin First Central Hospital, Tianjin

All Listed Sponsors
collaborator

Peking University

OTHER

lead

Chinese PLA General Hospital

OTHER