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This is a single arm, multi-center, phase II study to evaluate the efficacy and safety of tisagenlecleucel in Chinese pediatric and young adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
Full description
The study will have the following sequential phases for all subjects:
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Chinese patients age ≤25 years at the time of informed consent form (ICF) signature.
Relapsed or refractory B-cell ALL
For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of screening
Bone marrow with ≥ 5% lymphoblasts on local morphologic assessment at screening
Adequate performance status, cardiac, hepatic, renal and pulmonary function at screening
Must meet the institutional criteria to undergo leukapheresis
Once all other eligibility criteria are confirmed, must have a leukapheresis material of non-mobilized cells received and accepted for manufacturing.
Key Exclusion Criteria:
Primary purpose
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Data sourced from clinicaltrials.gov
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