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

NCT03265106 | Unknown Phase 1 DMC

• 1 other identifier: 2017FDEK-BinD19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Study treatment until Week 24

Secondary Outcomes (1)

• Overall Response [Efficacy]

  5 years

Study Arms (1)

BinD19

EXPERIMENTAL

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

BinD19 BIOLOGICAL

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.

BinD19

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• ECOG result is 3, 4 or 5.
• Pregnant or lactating female
• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• 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.

Sponsors & Collaborators

• Shenzhen BinDeBio Ltd.: lead
• Children's Hospital of Fudan University: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Burkitt Lymphoma; Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ZHONG HUA YANG

  Shenzhen BinDeBio Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: November 1, 2016
• Primary Completion: May 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)