Back to results

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

Primary Purpose

B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PZ01 CAR-T cells

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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
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

Sites / Locations

Department of Hematology, Navy General Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PZ01 CAR-T Cells

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Treatment Related Adverse Events

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

Overall response rate (ORR)

Proportion of patients with reduction in tumor burden.

Overall survival (OS)

Time from study enrollment until death.

Minimal residual disease negative remission rate(MRD)

Proportion of MRD-negative patients.

Full Information

NCT ID

NCT03281551

First Posted

September 9, 2017

Last Updated

September 14, 2017

Sponsor

Pinze Lifetechnology Co. Ltd.

Collaborators

Chinese Academy of Sciences, Navy General Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT03281551

Brief Title

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

Official Title

Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pinze Lifetechnology Co. Ltd.

Collaborators

Chinese Academy of Sciences, Navy General Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PZ01 CAR-T Cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PZ01 CAR-T cells

Intervention Description

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 Measure Information:

Title

Incidence of Treatment Related Adverse Events

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

Proportion of patients with reduction in tumor burden.

Time Frame

2 months

Title

Overall survival (OS)

Description

Time from study enrollment until death.

Time Frame

6 months

Title

Minimal residual disease negative remission rate(MRD)

Description

Proportion of MRD-negative patients.

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guoyan Wang

Phone

+86-018661838188

648818685@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shengdian Wang

Organizational Affiliation

Insitute of Biophysics,Chinese Academy of Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hematology, Navy General Hospital of PLA

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100048

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lixin Wang

Phone

86-013718000488

wgy@pinzelife.com

First Name & Middle Initial & Last Name & Degree

Jianliang Shen

First Name & Middle Initial & Last Name & Degree

Lixin Wang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs