Lymphoma, B-CellPhase 1NCT06792734
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
A Phase 1 study testing BTM-3566 in people with Lymphoma, B-Cell, run by Bantam Pharmaceuticals at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- BTM-3566
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- must be age ≥18 years
- must have a diagnosis of relapsed or refractory mature B cell lymphoma
- must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
- must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- must have a predicted life expectancy of ≥3 months
- must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566
Who cannot join
- has primary CNS lymphoma
- has ongoing toxicities from prior anti-cancer treatment > Grade 1
- has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
- has received any anti-cancer therapy (including radiation of curative intent) <28 days prior to administration of BTM-3566
- has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
- is pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Meghan Reynolds contact
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Institute, Atrium Health
Charlotte, North Carolina, 28204
Phase 1 Oncology Research Nurse, 800-804-9376, Alexandra.M.White@advocatehealth.org
Steven Park
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Luhua M Wang, MD, 713-792-2121
Luhua M Wang, MD
About this study
Official title: Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:
What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?
Read more
Participants will:
Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight
Read the detailed description
This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.
- Conditions
- Lymphoma, B-Cell
- Being tested
- BTM-3566
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTM-3566Drug
Also called BTM-3566 Oral Solution
Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| BTM-3566 Treatment | Experimental | BTM-3566 Oral Solution Receives: Drug: BTM-3566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event and dose-limiting toxicity event rates
The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bantam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Study director, Bantam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792734
- Sponsor's protocol ID
- BTM-3566-001
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
- ClinicalTrials.gov ID
- NCT06792734
- Acronym / sponsor ID
- BTM-3566-001
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bantam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jan 2025 (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.
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:
What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?
Participants will:
Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight
Detailed description
This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTM-3566 Treatment | Experimental | Drug: BTM-3566BTM-3566 Oral Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- must be age ≥18 years
- must have a diagnosis of relapsed or refractory mature B cell lymphoma
- must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
- must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- must have a predicted life expectancy of ≥3 months
Key exclusion criteria (6 listed)
- has primary CNS lymphoma
- has ongoing toxicities from prior anti-cancer treatment > Grade 1
- has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
- has received any anti-cancer therapy (including radiation of curative intent) <28 days prior to administration of BTM-3566
- has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
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 |
|---|---|---|
| BTM-3566Also: BTM-3566 Oral SolutionOral Solution | Drug | BTM-3566 Treatment |
Primary outcome
Adverse Event and dose-limiting toxicity event rates
Time frame: 24 months
The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Meghan Reynolds contact
Glen Weiss, MD study director
Bantam Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTM-3566 in people with Lymphoma, B-Cell, run by Bantam Pharmaceuticals at 2 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori McDermott (1-646-598-4823, lmcdermott@bantampharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event and dose-limiting toxicity event rates (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.