A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma

NCT06733441 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TLN-254-2401
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.

Conditions

Lymphoma

Keywords

Relapsed or refractory Cutaneous T Cell Lymphoma; Relapsed or refractory Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Objective Response

  Up to 2 years

• Percentage of Participants With CR

  Up to 2 years

• Percentage of Participants With PR

  Up to 2 years

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 2 years

• Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

  Up to 2 years

• Plasma concentrations of TLN-254

  Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)

• Duration of Response (DOR)

  Up to 2 years

Study Arms (2)

Cohort 1: TLN-254 Single Agent

EXPERIMENTAL

Drug: TLN-254

Cohort 2: TLN-254 Single Agent

EXPERIMENTAL

Drug: TLN-254

Interventions

TLN-254 DRUG

TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.

Cohort 1: TLN-254 Single Agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:
• At least 18 years of age at the time of signing the informed consent form (ICF).
• Type of Participant and Disease Characteristics:
• Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment.
• Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
• Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
• Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS.
• PTCL, NOS.
• Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive.
• Anaplastic large-cell lymphoma, ALK negative.
• Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
• Sezary syndrome
• Mycosis fungoides
• Participant must have measurable disease at study entry.
• Freshly biopsied or archival tissue available.

You may not qualify if:

• Medical Conditions:
• Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation.
• Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
• Current or past history of central nervous system (CNS) involvement.
• Pregnant or lactating women.
• Unable to swallow tablets.

Sponsors & Collaborators

• Treeline Biosciences, Inc.: lead

Study Sites (5)

Stanford Cancer Institute

Stanford, California, 94305, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma; Recurrence; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Central Study Contacts

Treeline Clinical Operations

CONTACT

857-228-0050; clinicaloperations@treeline.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2028
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)