Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06733441

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

Led by Treeline Biosciences, Inc. · Updated on 2025-10-10

50

Participants Needed

5

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age at the time of signing the informed consent form.
  • Peripheral T-cell lymphoma (PTCL) relapsed after or not responded to at least one prior systemic treatment. Participants with Anaplastic large cell lymphoma (ALCL) must have received prior brentuximab vedotin treatment.
  • PTCL subtypes include nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic, follicular helper T-cell lymphoma angioimmunoblastic type, nodal TFH cell lymphoma follicular type, nodal TFH cell lymphoma not otherwise specified, PTCL not otherwise specified, anaplastic large-cell lymphoma ALK positive, and ALK negative.
  • Relapsed or refractory cutaneous T-cell lymphoma (CTCL) relapsed after or not responded to at least two prior systemic treatments, including Sezary syndrome and Mycosis fungoides.
  • Measurable disease at study entry.
  • Freshly biopsied or archival tissue available.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate organ function.
  • Participants must accept and follow the pregnancy prevention plan.
Not Eligible

You will not qualify if you...

  • Prior systemic anti-cancer treatment within 5 half-lives or 4 weeks before starting the study treatment.
  • Allogeneic stem cell transplant within 90 days or autologous stem cell transplant within 60 days before study intervention.
  • Any significant acute or chronic medical illness, active or uncontrolled infection, or laboratory abnormalities that pose an unacceptable risk.
  • Current or past central nervous system (CNS) involvement.
  • Pregnant or lactating women.
  • Unable to swallow tablets.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Stanford Cancer Institute

Stanford, California, United States, 94305

Actively Recruiting

2

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

3

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

4

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

5

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Actively Recruiting

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Research Team

T

Treeline Clinical Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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