LGL LeukemiaPhase 1/2NCT03239392
A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL
A Phase 1/2 study testing BNZ132-1-40 in people with LGL Leukemia and CTCL, run by Bioniz Therapeutics at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LGL Leukemia, CTCL
- What is being tested?
- BNZ132-1-40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Apr 2018to 30 Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
The James Cancer Center, Ohio State University
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 10101
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma
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).
Read the 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 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).
- Conditions
- LGL Leukemia, CTCL
- Being tested
- BNZ132-1-40
- Keywords
- BNZ-1, Cytokine, IL-2, IL-15
- Medical subject headings
- Leukemia, Large Granular Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNZ132-1-40Drug
Also called BNZ-1
Injectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15
| Study group | Role | What they receive |
|---|---|---|
| BNZ-1 | Experimental | IV PEGylated BNZ132-1-40 Receives: Drug: BNZ132-1-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of treatment-emergent adverse events
Measured: 1 month
Incidence, severity and relationship of treatment-emergent adverse events
Measured: 4 months
Secondary outcomes (4)
Pharmacodynamics
Flow cytometry: Change from baseline over time for Tregs, NK cells and CD8+ central memory T-cells
Measured: 16 weeks
Single-dose and steady-state Cmax
Plasma levels of BNZ-1 will be measured after the 1st and last doses
Measured: 16 weeks
Single-dose and steady-state AUC
Plasma levels of BNZ-1 will be measured after the 1st and last doses
Measured: 16 weeks
Steady-state Elimination half-life (t1/2)
Plasma levels of BNZ-1 will be measured after the last dose
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start1 Apr 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LGL LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioniz Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Brammer, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239392
- Sponsor's protocol ID
- BNZ1-CT-201
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2017
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Brammer JE, Ballen K, Sokol L, Querfeld C, Nakamura R, Mishra A, McLaughlin EM, Feith D, Azimi N, Waldmann TA, Tagaya Y, Loughran T. Effective treatment with the selective cytokine inhibitor BNZ-1 reveals the cytokine dependency of T-LGL leukemia. Blood. 2023 Oct 12;142(15):1271-1280. doi: 10.1182/blood.2022017643.
PubMed 37352612
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03239392
- Acronym / sponsor ID
- BNZ1-CT-201
- Conditions
- LGL Leukemia, CTCL
- Keywords
- BNZ-1, Cytokine, IL-2, IL-15
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bioniz TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNZ-1 | Experimental | Drug: BNZ132-1-40IV PEGylated BNZ132-1-40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNZ132-1-40Also: BNZ-1Injectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15 | Drug | BNZ-1 |
Primary outcome
Incidence, severity and relationship of treatment-emergent adverse events
Time frame: 1 month
Incidence, severity and relationship of treatment-emergent adverse events
Time frame: 4 months
4 secondary outcomes
Pharmacodynamics
Time frame: 16 weeks
Single-dose and steady-state Cmax
Time frame: 16 weeks
Single-dose and steady-state AUC
Time frame: 16 weeks
Steady-state Elimination half-life (t1/2)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 37352612Brammer JE, Ballen K, Sokol L, Querfeld C, Nakamura R, Mishra A, McLaughlin EM, Feith D, Azimi N, Waldmann TA, Tagaya Y, Loughran T. Effective treatment with the selective cytokine inhibitor BNZ-1 reveals the cytokine dependency of T-LGL leukemia. Blood. 2023 Oct 12;142(15):1271-1280. doi: 10.1182/blood.2022017643.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Brammer, MD, PhD principal investigator
Ohio State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNZ132-1-40 in people with LGL Leukemia and CTCL, run by Bioniz Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship of treatment-emergent adverse events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.