Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
NCT ID: NCT03281551
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2017-10-01
2020-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
14 Years
65 Years
ALL
No
Sponsors
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Chinese Academy of Sciences
OTHER_GOV
Navy General Hospital, Beijing
OTHER
Pinze Lifetechnology Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Shengdian Wang
Role: PRINCIPAL_INVESTIGATOR
Insitute of Biophysics,Chinese Academy of Sciences
Locations
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Department of Hematology, Navy General Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PZ01
Identifier Type: -
Identifier Source: org_study_id