NCT06733441 · Treeline Biosciences, Inc.
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 treatment given alone in participants with relapsed or refractory T-cell lymphoma.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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
- Stanford, California
- St Louis, Missouri
- New York, New York
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations