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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
Children's Hospital of Fudan University
Information provided by (Responsible Party):
Shenzhen BinDeBio Ltd.

Brief Summary:
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in childhood patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.

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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: BinD19
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.
Biological: BinD19
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
  • CD19+ leukemia or lymphoma
  • Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
  • Follicular lymphoma, previously identified as CD19+:
  • Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
  • ECOG result is 0, 1 or 2.
  • With normal heart, liver and kidney functions.
  • Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody for HCV, HIV and syphilis.
  • Negative in pregnancy test (female subject only).

Exclusion Criteria:

  • ECOG result is 3, 4 or 5.
  • Pregnant or lactating female
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  • Previously treatment with any gene therapy products
  • HIV infection
  • Enrolled to other clinical study in the last 4 weeks.
  • Subjects with systemic auto-immune disease or immunodeficiency.
  • Subjects with CNS diseases.
  • Subjects with secondary tumors.
  • Subjects with tumor infiltration in liver, brain or GI tract.

Information from the National Library of Medicine

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): NCT03265106

Contact: QIU SHI ZHUANG, PhD 86-0755-86397905 qs.zhuang@siat.ac.cn

China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: HONGSHENG WANG, MD    86-021-64931990    honswang@hotmail.com   
Principal Investigator: HONGSHENG WANG, MD         
Sponsors and Collaborators
Shenzhen BinDeBio Ltd.
Children's Hospital of Fudan University
Study Director: QIU SHI ZHUANG, PhD Shenzhen BinDeBio Ltd.

Responsible Party: Shenzhen BinDeBio Ltd.
ClinicalTrials.gov Identifier: NCT03265106     History of Changes
Other Study ID Numbers: 2017FDEK-BinD19
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Burkitt Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections