NCT07180771

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
16mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Sep 2027

First Submitted

Initial submission to the registry

September 4, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

September 4, 2025

Last Update Submit

January 27, 2026

Conditions

Peripheral T Cell Lymphoma

Keywords

PTCLBosmolisibBR101801PI3K inhibitorDNA-PK

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

BR101801 (Bosmolisib)

EXPERIMENTAL

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

Drug: BR101801

Interventions

BR101801DRUG

Patients will receive 200mg capsules (100mg+100mg)

Also known as: Bosmolisib
BR101801 (Bosmolisib)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Shinyoung Oh

CONTACT

+82 2-708-8000syoh@boryung.co.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 18, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share