Status:
UNKNOWN
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects
Lead Sponsor:
Shenzhen BinDeBio Ltd.
Collaborating Sponsors:
Children's Hospital of Fudan University
Conditions:
Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03265106
Start Date
November 1 2016
End Date
December 30 2021
Last Update
February 4 2021
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102