Relapsed/Refractory B-cell MalignanciesPhase 1NCT06590961
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
A Phase 1 study testing UBX-303061 in people with Relapsed/Refractory B-cell Malignancies, run by Ubix Therapeutics, Inc. at 11 sites in 3 countries.
Trial summary
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory B-cell Malignancies
- What is being tested?
- UBX-303061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 20 Feb 2025to Aug 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
- Capable of giving signed informed consent
- Age ≥18 years
- ECOG performance status ≤2.
- Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
- Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
- All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
- Adequate organ and bone marrow function
Who cannot join
- For subjects with lymphoma:
- Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
- Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
- Unconjugated monoclonal antibody therapies <6 weeks before the first dose of study treatment.
- Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
- Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
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- Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
- History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
- Any immunotherapy within 4 weeks of first dose of study drug.
- The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is <5 times the t1/2 of the previously administered agent(s).
- Previously exposed to BTK degradation therapy
- Malignant disease, other than that being treated in this study.
- Radiotherapy within 2 weeks of the first dose of study treatment
- Known hypersensitivity to BTK degraders or any of the ingredients.
- Impaired cardiac function or clinically significant cardiac disease
- Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
- Major surgery within 4 weeks of the first dose of study treatment
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Poland4 sites, 4 recruiting
- Recruiting
AidPort
Grodzisk Wielkopolski, Wielkopolskie Voivodeship, 62-065
- Not yet recruiting
Pratia, Oncology Katowice
Katowice, Silesian Voivodeship, 40-519
- Recruiting
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
- Not yet recruiting
Pratia, MTZ Clinical Research
Warsaw, Mazowieckie Voivodeship, 02-172
South Korea4 sites, 4 recruiting
- Recruiting
Asan Medical Center
Seoul, Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, 06591
- Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Seoul, 07345
United States3 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Withdrawn
Gabrail Cancer Center
Canton, Oklahoma, 44718
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
- Conditions
- Relapsed/Refractory B-cell Malignancies
- Being tested
- UBX-303061
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBX-303061Drug
UBX-303061 oral dosage
| Study group | Role | What they receive |
|---|---|---|
| UBX-303061 | Experimental | UBX-303061 Receives: Drug: UBX-303061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Protocol Specified Dose-Limiting Toxicities
Phase 1a and 1b
Measured: 28-days
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
Phase 1a and 1b
Measured: Up to End of Treatment (up to 9 months)
Number of subjects with dose interruptions, reductions, and doses administered
Phase 1a and qb
Measured: Up to End of Treatment (up to 9 months)
Secondary outcomes (6)
To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response
Phase 1a and 1b
Measured: Up to End of Treatment (up to 9 months)
To assess genetic markers including but not limited to BTK, PLCG2, MYD88
Phase 1a and 1b
Measured: Up to End of Treatment (up to 9 months)
To assess Cmin
Phase 1a and 1b
Measured: 28-days
To assess tmax
Phase 1a and 1b
Measured: 28-days
To assess AUC
Phase 1a and 1b
Measured: 28-days
To assess Cmax
Phase 1a and 1b
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-cell MalignanciesStudies 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
- Sequential
- Model description
- Phase 1a: Dose escalation study Phase 1b: Dose expansion study
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ubix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590961
- Sponsor's protocol ID
- UBX-303-101
- Status last verified
- Oct 2025
- First submitted
- 27 Aug 2024
- Last updated
- 21 Oct 2026
- Results posted
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT06590961
- Acronym / sponsor ID
- UBX-303-101
- Conditions
- Relapsed/Refractory B-cell Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ubix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (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 is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1a: Dose escalation study Phase 1b: Dose expansion study
| Arm | Type | Receives |
|---|---|---|
| UBX-303061 | Experimental | Drug: UBX-303061UBX-303061 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of giving signed informed consent
- Age ≥18 years
- ECOG performance status ≤2.
- Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
- Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
Key exclusion criteria (17 listed)
- For subjects with lymphoma:
- Previously exposed to BTK degradation therapy
- Malignant disease, other than that being treated in this study.
- Radiotherapy within 2 weeks of the first dose of study treatment
- Known hypersensitivity to BTK degraders or any of the ingredients.
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 |
|---|---|---|
| UBX-303061UBX-303061 oral dosage | Drug | UBX-303061 |
Primary outcome
Number of subjects with Protocol Specified Dose-Limiting Toxicities
Time frame: 28-days
Phase 1a and 1b
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
Time frame: Up to End of Treatment (up to 9 months)
Phase 1a and 1b
Number of subjects with dose interruptions, reductions, and doses administered
Time frame: Up to End of Treatment (up to 9 months)
Phase 1a and qb
6 secondary outcomes
To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response
Time frame: Up to End of Treatment (up to 9 months)
To assess genetic markers including but not limited to BTK, PLCG2, MYD88
Time frame: Up to End of Treatment (up to 9 months)
To assess Cmin
Time frame: 28-days
To assess tmax
Time frame: 28-days
To assess AUC
Time frame: 28-days
To assess Cmax
Time frame: 28-days
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 21 Oct 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.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UBX-303061 in people with Relapsed/Refractory B-cell Malignancies, run by Ubix Therapeutics, Inc. at 11 sites in 3 countries.
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 7 inclusion and 17 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, South Korea, 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 Project Manager (+82 (2) 6334 2475, ubix_co@ubixtrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Protocol Specified Dose-Limiting Toxicities (time frame: 28-days). The study lists 3 primary outcomes in all. 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 21 Oct 2026.