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

Shenzhen BinDeBio

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Relapsed／Refractory B-cell Lymphoma; Refractory B-cell Acute Lymphoblastic Leukemia; Relapsed B-cell Acute Lymphoblastic Leukemia

Treatments: Biological: BinD19

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03156101

2017ZDYFY-BinD19

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 4 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

BinD19

Experimental group

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.

Treatment:

Biological: BinD19