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NCT07082803PHASE1Recruiting

TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

Treeline Biosciences, Inc.

Start Date

6/23/2025

Completion Date

11/1/2030

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

Age Range: 18 years to No maximum

Inclusion Criteria: Disease Characteristics 1. Participant must have measurable disease at study entry 2. Participants must have one of the following histologically documented hematologic malignancies: 1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following at least 2 prior lines of therapy. 2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy. 3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, 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-cell lymphoma, follicular type. * Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS. 3. High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2 prior systemic treatment regimens. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 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 CNS disease 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 of the study. 3. Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study. 4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study. 5. 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. 6. Pregnant or lactating. 7. Conditions that could affect drug absorption.

Interventions

DRUG

TLN-121

DRUG

TLN-254

DRUG

TLN-121

Interested in This Trial?

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Conditions

LymphomaLymphoma, Non Hodgkin

Locations

Stanford Medicine Cancer Center

Palo Alto, California 94304

United States

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan 49546

United States

Washington University School of Medicine

St Louis, Missouri 63108

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York 10065

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Macquarie University Hospital

Macquarie Park, New South Wales 2113

Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102

Australia

Cabrini Health

Malvern, Victoria 3144

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria

Australia

Linear Clinical Research

Perth, Western Australia 6009

Australia

BC Cancer - Vancouver

Vancouver, British Columbia V5Z 4E6

Canada