- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281551
Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
September 14, 2017 updated by: Pinze Lifetechnology Co. Ltd.
Study of Anti-CD19 Chimeric Antigen Receptor T Cells(PZ01) for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guoyan Wang
- Phone Number: +86-018661838188
- Email: 648818685@qq.com
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100048
- Recruiting
- Department of Hematology, Navy General Hospital of PLA
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Contact:
- Lixin Wang
- Phone Number: 86-013718000488
- Email: wgy@pinzelife.com
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Principal Investigator:
- Jianliang Shen
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Sub-Investigator:
- Lixin Wang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment Related Adverse Events
Time Frame: 1 year
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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.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 2 months
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Proportion of patients with reduction in tumor burden.
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2 months
|
Overall survival (OS)
Time Frame: 6 months
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Time from study enrollment until death.
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6 months
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Minimal residual disease negative remission rate(MRD)
Time Frame: 2 months
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Proportion of MRD-negative patients.
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2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shengdian Wang, Insitute of Biophysics,Chinese Academy of Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2017
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
September 9, 2017
First Submitted That Met QC Criteria
September 11, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PZ01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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