RECRUITING

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

Conditions

Lymphoma Relapsed or refractory Cutaneous T Cell Lymphoma Relapsed or refractory Peripheral T Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-12-16

Study Completion:2028-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06733441

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Catherine Maccaro, BS

CONTACT

646-608-2883

maccaroc@mskcc.org

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Treeline Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16

Study Completion Date2028-11-15

Study Record Updates

Study Start Date2024-12-16

Study Completion Date2028-11-15

Terms related to this study

Keywords Provided by Researchers

Relapsed or refractory Cutaneous T Cell Lymphoma
Relapsed or refractory Peripheral T Cell Lymphoma

Additional Relevant MeSH Terms

Lymphoma