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

NCT03265106 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-04

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Shenzhen BinDeBio Ltd.

    lead INDUSTRY

Principal Investigators

  • ZHONG HUA YANG · Shenzhen BinDeBio Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2021-05-30
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265106 on ClinicalTrials.gov