Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shenzhen BinDeBio Ltd.
With
Children's Hospital of Fudan University
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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).
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.
