Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03281551|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma||Drug: PZ01 CAR-T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma|
|Estimated Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
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.
- Incidence of Treatment Related Adverse Events [ Time Frame: 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.
- Overall response rate (ORR) [ Time Frame: 2 months ]Proportion of patients with reduction in tumor burden.
- Overall survival (OS) [ Time Frame: 6 months ]Time from study enrollment until death.
- Minimal residual disease negative remission rate(MRD) [ Time Frame: 2 months ]Proportion of MRD-negative patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281551
|Contact: Guoyan Wangfirstname.lastname@example.org|
|Department of Hematology, Navy General Hospital of PLA||Recruiting|
|Beijing, Beijing, China, 100048|
|Contact: Lixin Wang 86-013718000488 email@example.com|
|Principal Investigator: Jianliang Shen|
|Sub-Investigator: Lixin Wang|
|Principal Investigator:||Shengdian Wang||Insitute of Biophysics,Chinese Academy of Sciences|