Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
Conditions
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 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.
Interventions
BIOLOGICALBinD19
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.
Sponsors
Children's Hospital of Fudan University
Shenzhen BinDeBio Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events [Safety and Feasibility] | Study treatment until Week 24 | To evaluate the safety and feasibility of BinD19 CAR-T cells in patients with refractory /relapsed B-cell acute lymphoblastic leukemia or lymphoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed