Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 20, 2024

Primary Completion Date

March 20, 2026

Study Completion Date

March 20, 2027

Conditions
Non-hodgkin Lymphoma,B Cell
Interventions
BIOLOGICAL

Allogeneic CD19-STAR T cell

Phase 1 dose escalation (3+3): dose 1 (2×10\^6 cells/kg), dose 2 (6×10\^6 cells/kg), dose 3 (1.8×10\^7 cells/kg); Phase 2: dose of RP2D. No more than 5 × 10\^4 per kilogram of allogenic residual TCR-positive T cells harbouring in grafts can only be released for recipient infusion.

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 (2)

100853

RECRUITING

Biotherapeutic Department of Chinese PLA General Hospital, Beijing

Unknown

RECRUITING

School of medicine, Tsinghua University & Changping Laboratory, Beijing

All Listed Sponsors
lead

Chinese PLA General Hospital

OTHER