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New pill takes on tough blood cancers in first human trial

NCT ID NCT06590961

Disease control Sponsor: Ubix Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests an experimental oral drug called UBX-303061 in 94 adults with B-cell blood cancers (like certain lymphomas and leukemias) that have come back or not responded to at least two prior treatments. The main goals are to check safety, find the right dose, and see if the drug shows any anti-cancer activity. It is a first-in-human study, so results are very preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
UBX-303061 (oral drug)
What this could lead to
If successful, this could point toward a new oral treatment option for certain blood cancers that have stopped responding to other therapies.
What could go wrong
This is a very early, first-in-human trial with only 94 participants. The drug may not prove safe or effective, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria * 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 Key Exclusion Criteria * 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

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Conditions

The condition(s) this trial relates to.

neoplasm of mature B-cells Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory B-cell malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AidPort

    NOT_YET_RECRUITING

    Grodzisk Wielkopolski, Wielkopolskie Voivodeship, 62-065, Poland

  • Asan Medical Center

    RECRUITING

    Seoul, Seoul, 05505, South Korea

  • Gabrail Cancer Center

    RECRUITING

    Canton, Oklahoma, 44718, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MICS Centrum Medyczne Toruń

    NOT_YET_RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Pratia, MTZ Clinical Research

    NOT_YET_RECRUITING

    Warsaw, Mazowieckie Voivodeship, 02-172, Poland

  • Pratia, Oncology Katowice

    NOT_YET_RECRUITING

    Katowice, Silesian Voivodeship, 40-519, Poland

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    RECRUITING

    Seoul, Seoul, 06591, South Korea

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    RECRUITING

    Seoul, Seoul, 07345, South Korea

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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