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

Shenzhen BinDeBio Ltd.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BinD19BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

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.

Time frame: Study treatment until Week 24

Secondary Outcomes

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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