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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedSeptember 15, 2017
September 1, 2017
2.9 years
September 9, 2017
September 14, 2017
Conditions
Outcome Measures
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.
1 year
Secondary Outcomes (3)
Overall response rate (ORR)
2 months
Overall survival (OS)
6 months
Minimal residual disease negative remission rate(MRD)
2 months
Study Arms (1)
PZ01 CAR-T Cells
EXPERIMENTALThis is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pinze Lifetechnology Co. Ltd.lead
- Chinese Academy of Sciencescollaborator
- Navy General Hospital, Beijingcollaborator
Study Sites (1)
Department of Hematology, Navy General Hospital of PLA
Beijing, Beijing Municipality, 100048, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shengdian Wang
Insitute of Biophysics,Chinese Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2017
First Posted
September 13, 2017
Study Start
October 1, 2017
Primary Completion
September 1, 2020
Study Completion
November 1, 2020
Last Updated
September 15, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share