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

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.

Conditions

Lymphoma

Study Overview

Study Details

Study 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.

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

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

Condition
Lymphoma
Intervention / Treatment

-

Contacts and Locations

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. At least 18 years of age at the time of signing the informed consent form (ICF).
  • 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.
  • * Sezary syndrome
  • * Mycosis fungoides
  • 3. Participant must have measurable disease at study entry.
  • 4. Freshly biopsied or archival tissue available.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • 6. Adequate organ function.
  • 7. Participants must accept and follow the pregnancy prevention plan.
  • 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.
  • * Pregnant or lactating women.
  • * Unable to swallow tablets.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Treeline Biosciences, Inc.,

Study Record Dates

2028-11-15