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

Refractory B-cell Acute Lymphoblastic Leukemia, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03265106
• Other study ID #: 2017FDEK-BinD19
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2021
• Source: Shenzhen BinDeBio Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• BinD19
Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR- ?/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen BinDeBio Ltd.	Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years