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

Primary Purpose

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

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BinD19
Sponsored by
Shenzhen BinDeBio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

4 Years - 70 Years (Child, Adult, Older 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 antibody for EBV, CMV, HBV, HCV, HIV and syphilis.
  • Negative in pregnancy test （female subject only).

Exclusion Criteria:

  • ECOG result is 3, 4 or 5.
  • Pregnant or lactating women
  • 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

  • The First Affiliated Hospital of Zhengzhou 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 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]
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.

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

First Posted
May 15, 2017
Last Updated
February 3, 2021
Sponsor
Shenzhen BinDeBio Ltd.
Collaborators
The First Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT03156101
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects
Official Title
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory 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
March 2, 2017 (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
The First Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 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, Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed／Refractory B-cell Lymphoma

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
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BinD19
Arm Type
Experimental
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 patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.
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
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Time Frame
Study treatment until Week 24
Secondary Outcome Measure Information:
Title
Overall Response [Efficacy]
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 antibody for EBV, CMV, HBV, HCV, HIV and syphilis. Negative in pregnancy test （female subject only). Exclusion Criteria: ECOG result is 3, 4 or 5. Pregnant or lactating women 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
QIU SHI Zhuang, PhD
Organizational Affiliation
Shenzhen BinDeBio Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32580597
Citation
Chen X, Li X, Liu Y, Zhang Z, Zhang X, Huang J, Li H, Li F, Zhang L, Li L, Wu X, Ma W, Sun Z, Yu H, Zhou Z, Feng X, Cui K, Li Z, Zhang H, Zeng Y, Wan X, Chen YH, Zhang M, Zhang Y. A Phase I clinical trial of chimeric antigen receptor-modified T cells in patients with relapsed and refractory lymphoma. Immunotherapy. 2020 Jul;12(10):681-696. doi: 10.2217/imt-2020-0022. Epub 2020 Jun 25.
Results Reference
derived

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

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