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

• Sponsor: Pinze Lifetechnology Co. Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03281551
• Collaborator: Chinese Academy of Sciences (Other), Navy General Hospital, Beijing (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma	Drug: PZ01 CAR-T cells	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
• Anticipated Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall response rate (ORR) [2 months]

   Proportion of patients with reduction in tumor burden.

2. Overall survival (OS) [6 months]

   Time from study enrollment until death.

3. Minimal residual disease negative remission rate(MRD) [2 months]

   Proportion of MRD-negative patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. Getting through 2 treatments of standard chemotherapy with CR not yet obtained

5. Reach CR for the first inducement, but CR lasts for ≦12 months

6. r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment

7. ≧2 times of recurrence

8. Remedial chemotherapy is not used within 4 weeks before cell therapy

9. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy

10. Antibody drug treatment is not received within 2 weeks before cell therapy

11. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia

12. No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%

13. No contraindications for leukapheresis

14. Expected survival >3 months

15. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology, Navy General Hospital of PLA	Beijing	Beijing	China	100048

Sponsors and Collaborators

• Pinze Lifetechnology Co. Ltd.
• Chinese Academy of Sciences
• Navy General Hospital, Beijing

Investigators

• Principal Investigator: Shengdian Wang, Insitute of Biophysics,Chinese Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pinze Lifetechnology Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03281551
• Other Study ID Numbers: PZ01
• First Posted: Sep 13, 2017
• Last Update Posted: Sep 15, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell

Study Results

No Results Posted as of Sep 15, 2017