Clinical trial NCT03281551: Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Official title: Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma
Lead sponsor: Pinze Lifetechnology Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Sciences
name: Navy General Hospital, Beijing
First posted: 2017-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Incidence of Treatment Related Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 months
measure: Overall survival (OS)
timeFrame: 6 months
measure: Minimal residual disease negative remission rate(MRD)
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematology, Navy General Hospital of PLA
state: Beijing
Study officials:
affiliation: Insitute of Biophysics,Chinese Academy of Sciences
name: Shengdian Wang
role: PRINCIPAL_INVESTIGATOR
References: