TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

NCT ID: NCT07082803

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2030-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Lymphoma Lymphoma, Non Hodgkin

Keywords

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Relapsed or Refractory Non-Hodgkin Lymphomas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Agent

Group Type EXPERIMENTAL

TLN-121

Intervention Type DRUG

Specified dose on specified days.

Combination Treatment

Group Type EXPERIMENTAL

TLN-254

Intervention Type DRUG

Specified dose on specified days.

TLN-121

Intervention Type DRUG

Specified dose on specified days.

Interventions

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TLN-121

Specified dose on specified days.

Intervention Type DRUG

TLN-254

Specified dose on specified days.

Intervention Type DRUG

TLN-121

Specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Disease Characteristics

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. High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2 prior systemic treatment regimens.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

1. Participants must not have current central nervous system (CNS) involvement. Participants with past history of CNS involvement of lymphoma must have had CNS disease fully treated with no evidence of recurrence within 12 months.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Treeline Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Cabrini Health

Malvern, Victoria, Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

Linear Clinical Research

Perth, Western Australia, Australia

Site Status RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

Central Contacts

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Treeline Clinical Operations

Role: CONTACT

Phone: 857-228-0050

Email: [email protected]

Facility Contacts

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Andrew Sochacki

Role: primary

Amalia Dubois

Role: primary

Principal Investigator

Role: primary

Dai Chihara, Dr.

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Principal Investigator

Role: primary

Laurie Sehn

Role: primary

Other Identifiers

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TLN-121-2501

Identifier Type: -

Identifier Source: org_study_id