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

What this study 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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. Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
  • 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.
  • 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 be able to join if…

• 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 this trial is running

• 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

Who to contact

Treeline Clinical Operations · 857-228-0050 · clinicaloperations@treeline.bio

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06733441.