Trial | NCT03281551  Report issue

Title

Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
Study Started
Oct 01
2017
Anticipated
Primary Completion
Sep 01
2020
Anticipated
Study Completion
Nov 01
2020
Anticipated
Last Update
Sep 15
2017

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.

PZ01 CAR-T Cells Experimental

This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.

Criteria 

Inclusion Criteria:

Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology

In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:

Getting through 2 treatments of standard chemotherapy with CR not yet obtained
Reach CR for the first inducement, but CR lasts for ≦12 months
r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment
≧2 times of recurrence
Remedial chemotherapy is not used within 4 weeks before cell therapy
Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
Antibody drug treatment is not received within 2 weeks before cell therapy
Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
No contraindications for leukapheresis
Expected survival >3 months
Grade 0 or 1 of ECOG performance status

Exclusion Criteria:

Pregnant and breastfeeding women
Uncontrolled active infection
Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
Stage II-IV Acute/chronic general graft versus host disease
Gene therapy has been undergone in the past
No Results Posted