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UBX-303061 for Relapsed/Refractory B-Cell Malignancies

This study is testing a new oral medication called UBX-303061 for people with B-cell malignancies (cancers of certain white blood cells) that have returned or not responded to previous treatments. This is the first time UBX-303061 is being tested in humans. The main goals are to find a safe dose and see how well it works against the cancer. You might be able to join if you are at least 18 years old, have a B-cell malignancy like CLL/SLL or DLBCL, and have already tried at least two other treatments. The study is currently recruiting about 94 participants.

Study design
This is an open-label (meaning both you and your doctor will know what treatment you are receiving) study, designed to evaluate the safety and anti-cancer activity of UBX-303061. It is a Phase 1a/1b study, meaning it's an early-stage trial.
What's involved
The study will measure side effects and how well you tolerate the medication for up to 9 months.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects and how well you tolerate the medication for up to 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06590961

UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ubix Therapeutics, Inc.
~94 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:UBX-303061

At a glance

Recruiting sites
7 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with Protocol Specified Dose-Limiting Toxicities
Measured over 28-days
+2 more outcomes measured

Conditions

Relapsed/Refractory B-cell Malignancies

Explore related trials

B-Cell Malignant NeoplasmChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaSmall Lymphocytic LymphomaWaldenstrom Macroglobulinemia

Where it's being run

11 sites across 8 states
Seoul4
Michigan1
Oklahoma1
Texas1
Kuyavian-Pomeranian Voivodeship1
Mazowieckie Voivodeship1
Silesian Voivodeship1
Wielkopolskie Voivodeship1

Who to contact

Project Manager
[email protected]
+82 (2) 6334 2475
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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

What this trial measures

  • Number of subjects with Protocol Specified Dose-Limiting Toxicities28-days

    Phase 1a and 1b

  • To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)Up to End of Treatment (up to 9 months)

    Phase 1a and 1b

  • Number of subjects with dose interruptions, reductions, and doses administeredUp to End of Treatment (up to 9 months)

    Phase 1a and qb