A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

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.