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A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06733441•Treeline Biosciences, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+10 more criteria

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.

Locations (5)

Stanford Cancer Institute

Stanford, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Key Dates

Start Date

December 16, 2024

Primary Completion Date

November 15, 2026

Completion Date

November 15, 2028

Last Updated

October 10, 2025

Enrollment

ESTIMATED participants

Conditions

Lymphoma

Interventions

TLN-254

DRUG

TLN-254

DRUG

Contacts

Treeline Clinical Operations

CONTACT

857-228-0050 clinicaloperations@treeline.bio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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