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).
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:
- Screening Period
- 4-week Treatment Period
- 3-month Treatment Extension Period
- Long-term Extension Period (open-ended)
- 6-week Follow-up Period Subjects will be screened for eligibility within 30 days of
study Day 1 (first dosing day of the 4-Week Treatment Period).
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:
- Currently using two forms of effective birth control (one of which is a barrier
method) for the duration of the study for both males and females of childbearing
potential. Effective methods of birth control include hormonal contraception
(i.e., birth control pills, injected hormones, vaginal ring), intrauterine
device, or barrier methods with spermicide (i.e., diaphragm with spermicide,
condom with spermicide), or
- Surgically sterile (i.e., hysterectomy, tubal ligation, vasectomy).
- 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.
- Note: Complete blood count (CBC) and differential should be reported for the
phenotyped sample.
- Evidence for clonal T-cell receptor gene rearrangement (obtained within 1 year prior
to study drug administration).
CTCL-Specific:
- Histopathologically confirmed mycosis fungoides or Sézary syndrome (CTCL stage IIB or
greater according to the European Organization for Research and Treatment of
Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus
classification) at study entry with progressive, persistent, or recurrent disease who
have no available remaining standard therapeutic options (i.e., Refractory) as
determined by the Investigator.
Exclusion Criteria:
- Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine,
renal, or other major systemic disease making implementation of the protocol or
interpretation of the study results difficult, or that would put the subject at risk
by participating in the study in the opinion of the Investigator.
- History of or currently active primary or secondary immunodeficiency.
- Known active bacterial, viral, fungal, mycobacterial infection, or other infection
(including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal
infection of nail beds, minor upper respiratory tract infection, and minor skin
conditions]), or any major episode of infection that required hospitalization or
treatment with IV antibiotics within 30 days of study drug administration or oral
antibiotics within 14 days prior to study drug administration.
- Received other investigational products or therapy in the 60 days prior to study drug
administration.
