Evaluating TLN-254 for T-cell lymphoma that hasn't responded to treatment

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

This study is testing a new treatment called TLN-254 to see if it can help people with T-cell lymphoma that hasn’t responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Treeline Biosciences, Inc. (industry)
• Drugs / interventions: brentuximab
• Locations: 5 sites (Stanford, California and 4 other locations)
• Trial ID: NCT06733441 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of TLN-254, a novel therapeutic agent, in patients with relapsed or refractory T-cell lymphoma. Participants will receive TLN-254 monotherapy to evaluate its anti-tumor activity. The study includes two cohorts: one for patients with peripheral T-cell lymphoma and another for those with cutaneous T-cell lymphoma. The trial is designed to gather data on the drug's efficacy and safety in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory T-cell lymphoma who have not responded to previous treatments.

Not a fit: Patients with T-cell lymphoma that has not relapsed or refractory cases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with difficult-to-treat T-cell lymphomas.

How similar studies have performed: While there have been studies on T-cell lymphoma treatments, the specific approach with TLN-254 is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Stanford, California and 4 other locations

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

Study contacts

• Study coordinator: Treeline Clinical Operations

Conditions: Lymphoma, Relapsed or refractory Cutaneous T Cell Lymphoma, Relapsed or refractory Peripheral T Cell Lymphoma