Recruiting
Phase 1

UBX-303061

Sponsor:

Ubix Therapeutics, Inc.

Code:

NCT06590961

Conditions

Relapsed/Refractory B-cell Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UBX-303061

Study Details

Brief 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.

Conditions

Relapsed/Refractory B-cell Malignancies

Study ID

NCT06590961

Start date

Feb 20, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UBX-303061

UBX-303061

Interventions

UBX-303061

UBX-303061 oral dosage

Primary outcome measure

  • Number of subjects with Protocol Specified Dose-Limiting Toxicities [ Time Frame: 28-days ]
  • To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) [ Time Frame: Up to End of Treatment (up to 9 months) ]
  • Number of subjects with dose interruptions, reductions, and doses administered [ Time Frame: Up to End of Treatment (up to 9 months) ]

Central Contacts and Locations

Central contacts

Project Manager

+82 (2) 6334 2475ubix_co@ubixtrx.com

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Gabrail Cancer Center

Recruiting

Canton, Oklahoma, United States, 44718

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Ubix Therapeutics, Inc.

Last update posted

Nov 19, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ubix Therapeutics, Inc. on 2025-11-19.