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

Pinze Lifetechnology

Status and phase: Unknown; Phase 1

Conditions: B-cell Lymphoma; B-cell Acute Lymphoblastic Leukemia

Treatments: Drug: PZ01 CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03281551

PZ01

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

PZ01 CAR-T Cells

Experimental group

Description:

This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.

Treatment:

Drug: PZ01 CAR-T cells