Status:
RECRUITING
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Lead Sponsor:
Ubix Therapeutics, Inc.
Conditions:
Relapsed/Refractory B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06590961
Start Date
February 20 2025
End Date
August 1 2027
Last Update
November 19 2025
Active Locations (11)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Gabrail Cancer Center
Canton, Oklahoma, United States, 44718
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100