Study of Safety and Efficacy of BZ019 in (R/R) Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04250324|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Large B-cell Lymphoma||Biological: BZ019||Phase 1|
This is an open-label, multicenter, phase 1 study to determine the safety, PK, and antitumor activity of BZ019 in adult subjects with R/R large CD19+B cell lymphoma. The safety and efficacy of a single dose of different target doses of BZ019 will be evaluated in the dose-escalation phase and dose-expansion phase.
- To evaluate the safety and tolerance of single infusion of BZ019 in adult patients with relapsed or refractory large B-cell lymphoma, and to determine the maximum tolerable dose (MTD) and phase II recommended dose.
- To evaluate the pharmacokinetics and survival of BZ019 in the peripheral blood of adult patients with relapsed or refractory large B-cell lymphoma;
- To evaluate the Pharmacodynamic characteristics of BZ019 in adult patients with relapsed or refractory large B-cell lymphoma;
- Objective response rate (ORR), Overall survival, progression free survival, event free survival, and tumor progression time were used to evaluate the antitumor efficacy of BZ019 in the treatment of relapsed or refractory large B-cell lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection, for Relapsed and Refractory (R/R) Large B-cell Lymphoma|
|Actual Study Start Date :||November 19, 2019|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||December 2022|
The subjects are enrolled into 2 dose-escalation cohorts, include 3x10^6/kg、6x10^6/kg, and dose-expansion cohorts, maybe 8x10^6/kg、10x10^6/kg.
A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV).
- Dose-limiting toxicity (DLT) [ Time Frame: After 28 days of single infusion ]Safety
- Maximum tolerated dose (MTD) [ Time Frame: After 28 days of single infusion ]Tolerability
- Pharmacokinetics（the copies of cells in vivo） [ Time Frame: Month 24 ]Pharmacokinetics is defined as the number of copies of BZ019 DNA in peripheral blood at each visit after infusion until the test results are negative or below the detection limit. It aims to calculate the Peak Plasma Concentration (Cmax)
- Pharmacokinetics（the duration of survival of cells in vivo） [ Time Frame: Month 24 ]Duration of BZ019 persistence is the period from the day of infusion to the first negative test result. It aims to calculate the area under the plasma concentration versus time curve (AUC)
- Pharmacodynamics [ Time Frame: After 28 days of single infusion ]Pharmacodynamics is defined as the level of Cytokine, at least include IL-2, IL-4, IL-6, IL-10, IL-15, IFN-γ, TNF-α. The peak value of cytokines and their return to baseline were evaluated
- Antitumor efficacy-Objective response rate (ORR) [ Time Frame: Month 24 ]The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)
- Antitumor efficacy-Overall survival (OS) [ Time Frame: Month 24 ]The period from the first infusion to any cause of death
- Antitumor efficacy-Progression-free survival (PFS) [ Time Frame: Month 24 ]The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
- Antitumor efficacy-event -free survival (EFS) [ Time Frame: Month 24 ]Event free survival rate refers to the time from enrollment to occurrence of any event, including death, disease progression, change of chemotherapy program, change to chemotherapy, additional treatment, occurrence of lethal or intolerable side effects and other events.
- Antitumor efficacy- Tumor progression time (TTP) [ Time Frame: Month 24 ]Tumor progression time refers to the time from the beginning of the infusion of cells to tumor progression
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): NCT04250324
|Contact: Yan Sun, M.Dfirstname.lastname@example.org|
|Contact: Zhicai Lin, M.Demail@example.com|
|Hematology Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Tianjin, China, 300020|
|Contact: Lugui Qiu, prof. 022-23909282 firstname.lastname@example.org|
|Tianjin medical university cancer institute and hospital||Recruiting|
|Tianjin, China, 300060|
|Contact: Lanfang Li, prof. 022-23340123 ext 3210 email@example.com|
|Principal Investigator:||Lugui Qiu, Ph.D||Hematology Hospital, Chinese Academy of Medical Sciences|