TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

September 1, 2026

Conditions
Non Hodgkin's Lymphoma
Interventions
BIOLOGICAL

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."

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)

Unknown

RECRUITING

Biotherapeutic Department, Chinese PLA General Hospital, Beijing

RECRUITING

EdiGene Inc, Beijing

RECRUITING

School of Life Sciences, Peking University, Beijing

All Listed Sponsors
collaborator

Peking University

OTHER

collaborator

EdiGene Inc.

INDUSTRY

lead

Chinese PLA General Hospital

OTHER

NCT06014073 - TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL | Biotech Hunter | Biotech Hunter