UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

Exclusion Criteria17

• 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