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Status unknownNCT03265106Updated Feb 4, 2021

A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects

A Phase 1/2 interventional study of BinD19 in Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood and Relapsed/Refractory B-cell Lymphoma, Childhood, sponsored by Shenzhen BinDeBio Ltd.. Status unknown at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Shenzhen BinDeBio Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
  • Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
  • Relapsed/Refractory B-cell Lymphoma, Childhood
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • BiologicalBinD19

    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.

05

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events [Safety and Feasibility]

    To evaluate the safety and feasibility of BinD19 CAR-T cells in patients with refractory /relapsed B-cell acute lymphoblastic leukemia or lymphoma.

    Time frame: Study treatment until Week 24

Secondary outcomes

  1. Overall Response [Efficacy]

    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.

    Time frame: 5 years

06

Study locations

1 site
  • Children's Hospital of Fudan University
    Shanghai, Shanghai 201102, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03265106
Lead sponsor
Shenzhen BinDeBio Ltd.
Collaborators
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Nov 1, 2016
Primary completion
May 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Feb 4, 2021

Study contacts

ZHONG HUA YANG
study director · Shenzhen BinDeBio Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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