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

Phase 1b, Randomized, Dose Optimization Study to Assess the Anti-Tumor Activity, Safety, and Pharmacokinetics of TLN-254 in Patients With Relapsed or Refractory T-cell Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Drug: TLN-254; Drug: TLN-254

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Treeline Clinical Operations; Phone Number: 857-228-0050; Email: clinicaloperations@treeline.bio

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • British Columbia Cancer Agency
      • Contact: Kerry Savage; Phone Number: 672295 604-877-6000; Email: ksavage@bccancer.bc.ca
• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Cancer Institute
      • Contact: Nana Shakhnazaryan; Phone Number: 650-304-9443; Email: nshakhna@stanford.edu
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Molly Dubois, Sr. Clinical Research Coordinator; Phone Number: 314-273-1486; Email: amalia@wustl.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Catherine Maccaro; Phone Number: 646-608-2883; Email: maccaroc@mskcc.org
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
      • Contact: AskSarah Help Line; Phone Number: 844-482-4812

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Age:

1. At least 18 years of age at the time of signing the informed consent form (ICF).

   Type of Participant and Disease Characteristics:

2. 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
3. Participant must have measurable disease at study entry.

4. Freshly biopsied or archival tissue available.

   Diagnostic Assessments:

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

6. Adequate organ function.

   Contraception:

7. Participants must accept and follow the pregnancy prevention plan.

Exclusion Criteria:

Medical Conditions:

1. 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.
2. 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.
3. Current or past history of central nervous system (CNS) involvement.

Other Exclusions:

• Pregnant or lactating women.
• Unable to swallow tablets.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: TLN-254 Single Agent	Drug: TLN-254; TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.; Drug: TLN-254; TLN-254 will be administered orally at a specified dose on specified days.
Experimental: Cohort 2: TLN-254 Single Agent	Drug: TLN-254; TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.; Drug: TLN-254; TLN-254 will be administered orally at a specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Duration of Response (DOR)	Up to 2 years
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)

Collaborators and Investigators

• Sponsor: Treeline Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Relapsed or refractory Cutaneous T Cell Lymphoma; Relapsed or refractory Peripheral T Cell Lymphoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Lymphoma; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
• Other Study ID Numbers: TLN-254-2401

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No