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

A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: BR101801

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shinyoung Oh; Phone Number: +82 2-708-8000; Email: syoh@boryung.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR101801 (Bosmolisib); Patients will receive BR101801 capsules orally, QD in 28-day cycles	Drug: BR101801; Patients will receive 200mg capsules (100mg+100mg); Other Names: Bosmolisib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)		Up to 2 years
Overall Survival (OS)		Up to 2 years
Disease Control Rate (DCR)		Up to 2 years
Duration of Response (DOR)		Up to 2 years
Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria		Up to 2 years
Time to Tumor Progression (TTP)		Up to 2 years
Quality of life assessment Using the EQ-5D-5L assessment	European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health	Every 2 cycles for up to 24 months (each cycle is 28 days)
Quality of life assessment Using EORTC QLQ-C30 assessment	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Every 2 cycles for up to 24 months (each cycle is 28 days)
Plasma Concentration of BR101801 (Bosmolisib)	Blood samples were taken for the analyses of BR101801 in plasma at designated time points.	Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)
Adverse events		Approximately 24 months after a consent to the participation

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: September 16, 2025
• First Posted (Actual): September 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PTCL; PI3K inhibitor; DNA-PK; Bosmolisib; BR101801
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: BR-101801-CT-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No