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

Last updated: June 26, 2025
Sponsor: Treeline Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

TLN-254

Clinical Study ID

NCT06733441
TLN-254-2401
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 notresponded to at least one prior systemic treatment regimen. Participants withAnaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotintreatment.

  • Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicularhelper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-celllymphoma).

  • Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma,follicular type.

  • Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helperT-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 atleast two prior systemic treatments.

  • Sezary syndrome

  • Mycosis fungoides

  1. Participant must have measurable disease at study entry.

  2. Freshly biopsied or archival tissue available. Diagnostic Assessments:

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

  4. Adequate organ function. Contraception:

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

Exclusion

Exclusion Criteria:

Medical Conditions:

  1. Participants must not have prior systemic anti-cancer treatment less than or equalto (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 daysprior to study intervention initiation.

  2. Participants must not have any condition, including significant acute or chronicmedical illness, active or uncontrolled infection, or the presence of laboratoryabnormalities, that places participants at unacceptable risk if participating inthis study.

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

Other Exclusions:

  • Pregnant or lactating women.

  • Unable to swallow tablets.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: TLN-254
Phase: 1
Study Start date:
December 16, 2024
Estimated Completion Date:
November 15, 2028

Connect with a study center

  • British Columbia Cancer Agency

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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