NCT06590961 · Ubix Therapeutics, Inc.
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
What this study is about
This is a first-in-human Phase 1a/1b conducted at multiple hospitals, where both patients and doctors know the treatment given study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
- Canton, Oklahoma
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations