Not Yet RecruitingPhase 2

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

44 participantsStarted 2026-02

Plain-language 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).

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.

✕. 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:
✕. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\>20 mg/day prednisone or equivalent).

Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria

Timeframe: Up to 2 years

NCT IDNCT07180771

SponsorBoryung Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Shinyoung Oh

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.

✕. 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:
✕. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\>20 mg/day prednisone or equivalent).