A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.

This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.

Key Inclusion Criteria:

• The ECOG performance status ≤ 2.
• Life expectancy more than 3 months.
• Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification

• Peripheral T-cell lymphoma, not otherwise specified
• Nodal TFH cell lymphoma, angioimmunoblastic-type
• Nodal TFH cell lymphoma, follicular-type
• Nodal TFH cell lymphoma, NOS
• Patients currently requiring systemic therapy at the investigator's discretion.
• Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.

Key Exclusion Criteria:

• The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
• Impaired cardiac function or clinically significant cardiac disease.
• Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
• For patients with lymphoma:

• Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon [INF], and toxin immunoconjugates) 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.
• Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).