Trial | NCT03265106  Report issue

Title

A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Childhood R/R ALL and Lymphoma Subjects
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma Subjects

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    BinD19

  • Study Participants

    20
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 Started
Nov 01
2016
Primary Completion
May 30
2021
Anticipated
Study Completion
Dec 30
2021
Anticipated
Last Update
Feb 04
2021

Biological BinD19

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.

BinD19 Experimental

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 childhood patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.

Criteria 

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.
No Results Posted