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

B-cell Lymphoma Clinical Trial

Official title:

Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281551
• Other study ID #: PZ01
• Status: Recruiting
• Phase: Phase 1
• First received: September 9, 2017
• Last updated: September 14, 2017
• Start date: October 1, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: September 2017
• Source: Pinze Lifetechnology Co. Ltd.
• Contact: Guoyan Wang
• Phone: +86-018661838188
• Email: 648818685[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Department of Hematology, Navy General Hospital of PLA	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Pinze Lifetechnology Co. Ltd.	Chinese Academy of Sciences, Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Related Adverse Events	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.	1 year
Secondary	Overall response rate (ORR)	Proportion of patients with reduction in tumor burden.	2 months
Secondary	Overall survival (OS)	Time from study enrollment until death.	6 months
Secondary	Minimal residual disease negative remission rate(MRD)	Proportion of MRD-negative patients.	2 months