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

Shenzhen BinDeBio Ltd.20 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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 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 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.

Outcomes

Primary Outcomes

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.

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