CompletedPhase 1/2

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

United States50 participantsStarted 2018-04-01

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, severity and relationship of treatment-emergent adverse events

Timeframe: 1 month

Incidence, severity and relationship of treatment-emergent adverse events

Timeframe: 4 months

Trial details

NCT IDNCT03239392

SponsorBioniz Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-30

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