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

Phase 1

• Conditions: Relapsed／Refractory B-cell Lymphoma; Refractory B-cell Acute Lymphoblastic Leukemia; Relapsed B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: BinD19

• Registration Number: NCT03156101
• Lead Sponsor: Shenzhen BinDeBio Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-02
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-05-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BinD19	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 patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events [Safety and Feasibility]	Study treatment until Week 24	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

Name	Time	Method
Overall Response [Efficacy]	5 years	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China