RECRUITING

A Study of TLN-121 in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas

Conditions

Lymphoma Lymphoma, Non Hodgkin Relapsed or Refractory Non-Hodgkin Lymphomas

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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 safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas

Official Title

An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and in Combination With Other Anti-Lymphoma Agents, in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas

Quick Facts

Study Start:2025-06-23

Study Completion:2030-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07082803

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. Participant must have measurable disease at study entry 2. Participants must have one of the following histologically documented hematologic malignancies: 1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following at least 2 prior lines of therapy. 2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy. 3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen: * Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL). * Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type. * Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.	1. Participants must not have current or past history of central nervous system (CNS) involvement. 2. Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study. 3. Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study. 4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study. 5. 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. 6. Pregnant or lactating. 7. Conditions that could affect drug absorption.

Inclusion Criteria

Exclusion Criteria

1. Participant must have measurable disease at study entry
2. Participants must have one of the following histologically documented hematologic malignancies:
1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following at least 2 prior lines of therapy.
2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.
3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen:
* Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
* Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
* Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

1. Participants must not have current or past history of central nervous system (CNS) involvement.
2. Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study.
3. Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study.
4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
5. 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.
6. Pregnant or lactating.
7. Conditions that could affect drug absorption.

Contacts and Locations

Study Contact

Elizabeth Webber

CONTACT

603-401-8894

ewebber@treeline.bio

Study Locations (Sites)

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, 49546

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 Date2025-06-23

Study Completion Date2030-11

Study Record Updates

Study Start Date2025-06-23

Study Completion Date2030-11

Terms related to this study

Keywords Provided by Researchers

Relapsed or Refractory Non-Hodgkin Lymphomas

Additional Relevant MeSH Terms

Lymphoma
Lymphoma, Non Hodgkin