Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

PHASE1UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2017

Primary Completion Date

September 1, 2020

Study Completion Date

November 1, 2020

Conditions
B-cell Acute Lymphoblastic LeukemiaB-cell Lymphoma
Interventions
DRUG

PZ01 CAR-T cells

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Trial Locations (1)

100048

RECRUITING

Department of Hematology, Navy General Hospital of PLA, Beijing

Sponsors
All Listed Sponsors
collaborator

Chinese Academy of Sciences

OTHER_GOV

collaborator

Navy General Hospital, Beijing

OTHER

lead

Pinze Lifetechnology Co. Ltd.

INDUSTRY

NCT03281551 - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma | Biotech Hunter | Biotech Hunter