BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 20, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Acute Lymphocytic Leukemia
Interventions
BIOLOGICAL

CAR19TIF cells

"Phase 1 dose escalation/decline (3+3) :~starting dose: 5×10\^5 cells/kg, According to effective expansion and clinical efficacy data, a descending dose escalation model will be adopted: such as 1×10\^5 cells/kg, 5×10\^4 cells/kg.~If the 5×10\^5 cells/kg dose group does not achieve efficient expansion and clinical benefit, an ascending dose escalation model will be adopted, such as 2×10\^6 cells/kg, 6×10\^6 cells/kg.~Phase 2 : dose of RP2D."

DRUG

Fludarabine

"Intravenous fludarabine 25\~30 mg/m\^2/day on days~-5, -4, and -3."

DRUG

Cyclophosphamide

Intravenous cyclophosphamide 250\~500 mg/m\^2/day on days -5, -4, and -3.

Trial Locations (2)

Unknown

RECRUITING

China, Beijing

NOT_YET_RECRUITING

China, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER

NCT07008885 - BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B-ALL | Biotech Hunter | Biotech Hunter