Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

Phase 1

• Conditions: B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma
• Interventions: Drug: PZ01 CAR-T cells

• Registration Number: NCT03281551
• Lead Sponsor: Pinze Lifetechnology Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-09
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15
• Study Start: 2017-10-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PZ01 CAR-T Cells	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Related Adverse Events	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	2 months	Proportion of patients with reduction in tumor burden.
Overall survival (OS)	6 months	Time from study enrollment until death.
Minimal residual disease negative remission rate(MRD)	2 months	Proportion of MRD-negative patients.

Trial Locations

Locations (1)

Department of Hematology, Navy General Hospital of PLA; 🇨🇳 Beijing, Beijing, China