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This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).
Full description
This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The study has 5 periods:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Willing and able to consent and participate in the study.
Agrees not to receive any other investigational product or therapy while participating in this study.
Must be:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
Life expectancy >1 year.
LGL-Specific:
Phenotypic studies (obtained within 8 weeks prior to study drug administration) from peripheral blood showing CD3+, CD57+ cells >400/mm³ or CD8+ cells >650/mm³.
Evidence for clonal T-cell receptor gene rearrangement (obtained within 1 year prior to study drug administration).
CTCL-Specific:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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