A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma
NCT ID: NCT06733441
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2024-12-16
2028-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: TLN-254 Single Agent
TLN-254
TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
Cohort 2: TLN-254 Single Agent
TLN-254
TLN-254 will be administered orally at a specified dose on specified days.
Interventions
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TLN-254
TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
TLN-254
TLN-254 will be administered orally at a specified dose on specified days.
Eligibility Criteria
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Inclusion Criteria
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.
Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
* Sezary syndrome
* Mycosis fungoides
3. Participant must have measurable disease at study entry.
4. Freshly biopsied or archival tissue available.
Diagnostic Assessments:
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
6. Adequate organ function.
Contraception:
7. Participants must accept and follow the pregnancy prevention plan.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Treeline Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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AskSarah Help Line
Role: primary
Other Identifiers
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TLN-254-2401
Identifier Type: -
Identifier Source: org_study_id
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