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NCT Number: NCT06733441

A Study of TLN-254 in Participants 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Diagnostic Assessments:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate organ function.

Contraception:

  • Participants must accept and follow the pregnancy prevention plan.

Exclusion criteria

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.

Other Exclusions:

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

Treatment and study plan

TLN-254

Drug

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

Primary outcomes

  1. Percentage of Participants With Objective Response

    Time frame: Up to 2 years

  2. Percentage of Participants With CR

    Time frame: Up to 2 years

  3. Percentage of Participants With PR

    Time frame: Up to 2 years

Secondary outcomes

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  3. Plasma concentrations of TLN-254

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

  4. Duration of Response (DOR)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Treeline Clinical Operations

CONTACT

[email protected]

857-228-0050

Sponsors and collaborators

Lead sponsor

Treeline Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 13, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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