Status:
NOT_YET_RECRUITING
A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Peripheral T Cell Lymphoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Detailed Description
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07180771
Start Date
September 1 2025
End Date
September 1 2027
Last Update
September 18 2025
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