Evaluating UBX-303061 for patients with relapsed/refractory B-cell cancers

A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

This study is testing a new treatment called UBX-303061 to see if it can help people with tough-to-treat B-cell cancers feel better after other treatments have failed.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ubix Therapeutics, Inc. (industry)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy
• Locations: 11 sites (Ann Arbor, Michigan and 10 other locations)
• Trial ID: NCT06590961 on ClinicalTrials.gov

What this trial studies

This Phase 1a/1b multicenter, open-label study aims to assess the safety and anti-cancer efficacy of UBX-303061 in individuals suffering from relapsed or refractory B-cell malignancies. The trial includes a dose-escalation phase for patients who have undergone at least two prior therapies and have no available treatment options. Participants will be monitored for measurable disease and must meet specific organ function criteria to qualify for the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell malignancies who have received at least two prior therapies.

Not a fit: Patients who have not received prior therapies or those with active systemic antineoplastic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited alternatives for relapsed or refractory B-cell malignancies.

How similar studies have performed: While this approach is novel, similar studies targeting B-cell malignancies have shown promise in the past.

Eligibility criteria

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

Where this trial is running

Ann Arbor, Michigan and 10 other locations

• University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
• Gabrail Cancer Center — Canton, Oklahoma, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• MICS Centrum Medyczne Toruń — Torun, Kuyavian-Pomeranian Voivodeship, Poland (NOT_YET_RECRUITING)
• Pratia, MTZ Clinical Research — Warsaw, Mazowieckie Voivodeship, Poland (NOT_YET_RECRUITING)
• Pratia, Oncology Katowice — Katowice, Silesian Voivodeship, Poland (NOT_YET_RECRUITING)
• AidPort — Grodzisk Wielkopolski, Wielkopolskie Voivodeship, Poland (NOT_YET_RECRUITING)
• Asan Medical Center — Seoul, Seoul, South Korea (RECRUITING)
• Samsung Medical Center — Seoul, Seoul, South Korea (RECRUITING)
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, Seoul, South Korea (RECRUITING)
• The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Project Manager

Conditions: Relapsed/Refractory B-cell Malignancies