This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. The ECOG performance status ≤ 2.
2. Life expectancy more than 3 months.
3. 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
4. Patients currently requiring systemic therapy at the investigator's discretion.
5. 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.
You may not be if
1. 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.
2. Impaired cardiac function or clinically significant cardiac disease.
3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
4. 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.
5. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\>20 mg/day prednisone or equivalent).
Clareo Health | A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.
