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

Recruiting now · Phase 1

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT06733441

Run by

Treeline Biosciences, Inc.

People needed

50

Starts

2024-12-16

Expected to finish

2028-11-15

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age:
• At least 18 years of age at the time of signing the informed consent form (ICF).
• Type of Participant and Disease Characteristics:
• 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.
• Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
• Sezary syndrome
• Mycosis fungoides
• Participant must have measurable disease at study entry.
• Freshly biopsied or archival tissue available.
• Diagnostic Assessments:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Adequate organ function.
• Contraception:
• Participants must accept and follow the pregnancy prevention plan.

You may not qualify if…

• Medical Conditions:
• 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.
• 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.
• Current or past history of central nervous system (CNS) involvement.
• Other Exclusions:
• Pregnant or lactating women.
• Unable to swallow tablets.

Where it is running

• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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