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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03281551
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 15, 2017
Chinese Academy of Sciences
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Pinze Lifetechnology Co. Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma Drug: PZ01 CAR-T cells Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Anti-CD19 Chimeric Antigen Receptor T Cells(PZ01) for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: PZ01 CAR-T Cells
This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.
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.

Primary Outcome Measures :
  1. Incidence of Treatment Related Adverse Events [ Time Frame: 1 year ]
    To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 2 months ]
    Proportion of patients with reduction in tumor burden.

  2. Overall survival (OS) [ Time Frame: 6 months ]
    Time from study enrollment until death.

  3. Minimal residual disease negative remission rate(MRD) [ Time Frame: 2 months ]
    Proportion of MRD-negative patients.

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
  2. 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
  3. In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:

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

Exclusion Criteria:

  1. Pregnant and breastfeeding women
  2. Uncontrolled active infection
  3. Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
  4. Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
  5. Stage II-IV Acute/chronic general graft versus host disease
  6. Gene therapy has been undergone in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03281551

Contact: Guoyan Wang +86-018661838188

China, Beijing
Department of Hematology, Navy General Hospital of PLA Recruiting
Beijing, Beijing, China, 100048
Contact: Lixin Wang    86-013718000488   
Principal Investigator: Jianliang Shen         
Sub-Investigator: Lixin Wang         
Sponsors and Collaborators
Pinze Lifetechnology Co. Ltd.
Chinese Academy of Sciences
Navy General Hospital, Beijing
Principal Investigator: Shengdian Wang Insitute of Biophysics,Chinese Academy of Sciences

Responsible Party: Pinze Lifetechnology Co. Ltd. Identifier: NCT03281551     History of Changes
Other Study ID Numbers: PZ01
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Epstein-Barr Virus Infections
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Burkitt Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections