A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects
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|ClinicalTrials.gov Identifier: NCT03265106|
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood Refractory B-cell Acute Lymphoblastic Leukemia, Childhood Relapsed/Refractory B-cell Lymphoma, Childhood||Biological: BinD19||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 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 Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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 childhood 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265106
|Contact: QIU SHI ZHUANG, PhDfirstname.lastname@example.org|
|Children's Hospital of Fudan University||Recruiting|
|Shanghai, Shanghai, China, 201102|
|Contact: HONGSHENG WANG, MD 86-021-64931990 email@example.com|
|Principal Investigator: HONGSHENG WANG, MD|
|Study Director:||QIU SHI ZHUANG, PhD||Shenzhen BinDeBio Ltd.|