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RecruitingInterventionalPhase 1

Phase 1b, Randomized, Dose Optimization Study to Assess the Anti-Tumor Activity, Safety, and Pharmacokinetics of TLN-254 in Patients With Relapsed or Refractory T-cell Lymphoma

NCT ID: NCT06733441Sponsor: Treeline Biosciences, Inc.Last updated: 2025-10-10

Summary

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.

Arms & interventions

  • DrugTLN-254

    TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.

  • DrugTLN-254

    TLN-254 will be administered orally at a specified dose on specified days.

Outcome measures

Primary

  • Percentage of Participants With Objective Response

    Time frame: Up to 2 years

  • Percentage of Participants With CR

    Time frame: Up to 2 years

  • Percentage of Participants With PR

    Time frame: Up to 2 years

Secondary

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 2 years

  • Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

    Time frame: Up to 2 years

  • Plasma concentrations of TLN-254

    Time frame: Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)

  • Duration of Response (DOR)

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: Age: 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: Medical Conditions: 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.

Study locations (4)

Stanford Cancer Institute

Stanford, California, 94305

Recruiting
Nana Shakhnazaryan · Contact

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Molly Dubois, Sr. Clinical Research Coordinator · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Catherine Maccaro · Contact

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting
AskSarah Help Line · Contact