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

Primary Purpose

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

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BinD19

About this trial

This is an interventional treatment trial for Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BinD19

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03265106

First Posted

August 25, 2017

Last Updated

February 3, 2021

Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03265106

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2016 (Actual)

Primary Completion Date

May 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen BinDeBio Ltd.

Collaborators

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BinD19

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

BinD19

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events [Safety and Feasibility]

Description

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 Outcome Measure Information:

Title

Overall Response [Efficacy]

Description

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ZHONG HUA YANG

Organizational Affiliation

Shenzhen BinDeBio Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201102

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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