TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

Last updated: March 25, 2026
Sponsor: Treeline Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Treatment

TLN-121

TLN-254

Clinical Study ID

NCT07082803
TLN-121-2501
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas

Eligibility Criteria

Inclusion

Inclusion Criteria:

Disease Characteristics

  1. Participant must have measurable disease at study entry

  2. Participants must have one of the following histologically documented hematologicmalignancies:

  3. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS),Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following atleast 2 prior lines of therapy.

  4. FL grade 1-3a that requires treatment following at least 2 prior lines oftherapy.

  5. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsedafter, or not responded to at least 1 prior systemic treatment regimen:

  • Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic;Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
  • Nodal Tfh cell lymphoma, follicular type; Follicular helper T-celllymphoma, follicular type.
  • Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.
  1. High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2prior systemic treatment regimens.

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

Exclusion

Exclusion Criteria:

  1. Participants must not have current central nervous system (CNS) involvement.Participants with past history of CNS involvement of lymphoma must have had CNSdisease fully treated with no evidence of recurrence within 12 months.

  2. Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start ofthe study.

  3. Participant must not have a history of CAR T-cell or other T-cell targetingtreatment ≤ 4 weeks prior to the start of the study.

  4. Participant must not have major surgery or severe trauma within 4 weeks prior to thestart of the study.

  5. 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.

  6. Pregnant or lactating.

  7. Conditions that could affect drug absorption.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: TLN-121
Phase: 1
Study Start date:
June 23, 2025
Estimated Completion Date:
November 30, 2030

Connect with a study center

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2113
    Australia

    Active - Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Macquarie University Hospital

    Macquarie Park 8347858, New South Wales 2155400 2113
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Cabrini Health

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • Cabrini Health

    Malvern 2158952, Victoria 2145234 3144
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234
    Australia

    Site Not Available

  • Linear Clinical Research

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Perth 2063523, Western Australia 2058645 6009
    Australia

    Site Not Available

  • BC Cancer - Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BC Cancer - Vancouver

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • Stanford Medicine Cancer Center

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford Medicine Cancer Center

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • The START Center for Cancer Care - Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • The START Center for Cancer Care - Midwest

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63108
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63108
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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