A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 18, 2023

Primary Completion Date

March 18, 2025

Study Completion Date

March 18, 2026

Conditions
Relapsed/refractory LymphomaRelapsed/Refractory Leukemia
Interventions
BIOLOGICAL

anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells

"Each subject will be infused with single dose. A classic 3+3 dose escalation will be employed.~anti-CD19-CAR T-cells~Dose level 1:1x10\^5 CAR T cells/kg, Dose level 2:3x10\^5 CAR T cells/kg, Dose level 3:1x10\^6 CAR T cells/kg~anti-CD30-CAR T-cells~Dose level 1:3x10\^6 CAR T cells/kg, Dose level 2:6x10\^6 CAR T cells/kg, Dose level 3:1x10\^7 CAR T cells/kg~anti-CD20/CD30-CAR T-cells~Dose level 1:1x10\^6 CAR T cells/kg, Dose level 2:3x10\^6 CAR T cells/kg, Dose level 3:1x10\^7 CAR T cells/kg"

DRUG

Fludarabine

Fludarabine will be given at a dose of 25 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

DRUG

Cyclophosphamide

Cyclophosphamide will be given at a dose of 250 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

Trial Locations (1)

226001

RECRUITING

Affiliated Hospital of Nantong University, Nantong

All Listed Sponsors
collaborator

Shanghai First Song Biotechnology Co., LTD

INDUSTRY

lead

Affiliated Hospital of Nantong University

OTHER

NCT06756321 - A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy | Biotech Hunter | Biotech Hunter