Status:
UNKNOWN
Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Lead Sponsor:
Pinze Lifetechnology Co. Ltd.
Collaborating Sponsors:
Chinese Academy of Sciences
Navy General Hospital, Beijing
Conditions:
B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma
Eligibility:
All Genders
14-65 years
Phase:
PHASE1
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03281551
Start Date
October 1 2017
End Date
November 1 2020
Last Update
September 15 2017
Active Locations (1)
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1
Department of Hematology, Navy General Hospital of PLA
Beijing, Beijing Municipality, China, 100048