A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects
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|ClinicalTrials.gov Identifier: NCT03156101|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2017
Last Update Posted : February 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed B-cell Acute Lymphoblastic Leukemia Refractory B-cell Acute Lymphoblastic Leukemia Relapsed／Refractory B-cell Lymphoma||Biological: BinD19||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Acute Lymphoblastic Leukemia and Lymphoma Subjects|
|Actual Study Start Date :||March 2, 2017|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/maximum dose: 1x10^6/kg / 1x10^7/kg administered to patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.
Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
- Number of Participants With Adverse Events [Safety and Feasibility] [ Time Frame: Study treatment until Week 24 ]Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
- Overall Response [Efficacy] [ Time Frame: 5 years ]Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. Efficacy assessments for Lymphoma were based on tumor load, B cell number and immunoglobulins.
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): NCT03156101
|The First Affiliated Hospital of Zhengzhou University|
|Zhengzhou, Henan, China, 450052|
|Study Director:||QIU SHI Zhuang, PhD||Shenzhen BinDeBio Ltd.|