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Recruiting NCT06733441

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

Phase I Interventional Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TLN-254, TLN-254.
Who it may be relevant to
Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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 outcome measures (4)
  • 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

Inclusion criteria

Age:

  • 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.
  • 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Stanford Cancer Institute — Stanford
  • Washington University School of Medicine — St Louis
  • Memorial Sloan Kettering Cancer Center — New York
  • Sarah Cannon Research Institute — Nashville
Canada · 1 center
  • British Columbia Cancer Agency — Vancouver

Identifiers

NCT: NCT06733441 · TLN-254-2401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗