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

NCT ID: NCT03265106

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2021-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BinD19

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Shenzhen BinDeBio Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ZHONG HUA YANG

Role: STUDY_DIRECTOR

Shenzhen BinDeBio Ltd.

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2017FDEK-BinD19

Identifier Type: -

Identifier Source: org_study_id