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Status unknownNCT03281551Updated Sep 15, 2017

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

A Phase 1 interventional study of PZ01 CAR-T cells in B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma, sponsored by Pinze Lifetechnology Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Pinze Lifetechnology Co. Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
14 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Lymphoma
03

In context

Burkitt Lymphoma

407 studies on the registry are indexed under Burkitt Lymphoma; 117 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 363 interventional studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

This is the only study on the registry with Pinze Lifetechnology Co. Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • DrugPZ01 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. Overall response rate (ORR)

    Proportion of patients with reduction in tumor burden.

    Time frame: 2 months

  2. Overall survival (OS)

    Time from study enrollment until death.

    Time frame: 6 months

  3. Minimal residual disease negative remission rate(MRD)

    Proportion of MRD-negative patients.

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology, Navy General Hospital of PLA
    Beijing, Beijing Municipality 100048, China
    • Lixin Wang · Contact · wgy@pinzelife.com · 86-013718000488
    • Jianliang Shen · Principal investigator
    • Lixin Wang · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03281551
Lead sponsor
Pinze Lifetechnology Co. Ltd.
Collaborators
Chinese Academy of Sciences, Navy General Hospital, Beijing
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Oct 1, 2017 (estimated)
Primary completion
Sep 1, 2020 (estimated)
Completion
Nov 1, 2020 (estimated)
Last update
Sep 15, 2017

Study contacts

Guoyan Wang
Contact
648818685@qq.com
+86-018661838188
Shengdian Wang
principal investigator · Insitute of Biophysics,Chinese Academy of Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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