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

Boryung

Status and phase: Not yet enrolling; Phase 2

Conditions: Peripheral T Cell Lymphoma

Treatments: Drug: BR101801

Study type: Interventional

Funder types: Industry

Identifiers

NCT07180771

BR-101801-CT-201

Details and patient eligibility

About

The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).

Full description

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

Enrollment: 44 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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
   • Nodal TFH cell lymphoma, angioimmunoblastic-type
   • Nodal TFH cell lymphoma, follicular-type
   • Nodal TFH cell lymphoma, NOS

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.

Key Exclusion Criteria:

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

BR101801 (Bosmolisib)

Experimental group

Description:

Patients will receive BR101801 capsules orally, QD in 28-day cycles

Treatment:

Drug: BR101801