Status:
COMPLETED
A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL
Lead Sponsor:
Bioniz Therapeutics
Conditions:
LGL Leukemia
CTCL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 inf...
Detailed 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 inf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03239392
Start Date
April 1 2018
End Date
June 30 2020
Last Update
May 25 2021
Active Locations (4)
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1
City of Hope National Medical Center
Duarte, California, United States, 10101
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
The James Cancer Center, Ohio State University
Columbus, Ohio, United States, 43210
4
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908