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

Not Applicable

Not yet recruiting

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Drug: BR101801

• Registration Number: NCT07180771
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BR101801 (Bosmolisib)	BR101801	Patients will receive BR101801 capsules orally, QD in 28-day cycles

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall Survival (OS)	Up to 2 years
Disease Control Rate (DCR)	Up to 2 years
Duration of Response (DOR)	Up to 2 years
Progression-free Survival (PFS)	Up to 2 years
Time to Tumor Progression (TTP)	Up to 2 years
Quality of life assessment Using the EQ-5D-5L assessment	Every 2 cycles for up to 24 months (each cycle is 28 days)	European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health
Quality of life assessment Using EORTC QLQ-C30 assessment	Every 2 cycles for up to 24 months (each cycle is 28 days)	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.
Plasma Concentration of BR101801 (Bosmolisib)	Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)	Blood samples were taken for the analyses of BR101801 in plasma at designated time points.
Adverse events	Approximately 24 months after a consent to the participation