A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects

Shenzhen BinDeBio Ltd.1 site in 1 country20 target enrollmentNovember 1, 2016

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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
Sponsor: Shenzhen BinDeBio Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events [Safety and Feasibility]
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2016

End Date

December 30, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shenzhen BinDeBio Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•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.