Recruiting
Phase 1

TLN-121

Sponsor:

Treeline Biosciences, Inc.

Code:

NCT07082803

Conditions

Lymphoma

Lymphoma, Non Hodgkin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TLN-121

zeprumetostat (TLN-254)

TLN-121

Study Details

Brief summary:

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

Conditions

Lymphoma

Lymphoma, Non Hodgkin

Study ID

NCT07082803

Start date

Jun 23, 2025

Status verified date

Sep, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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. Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBLC), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, transformed lymphoma from FL, or High-Grade B-Cell lymphoma (HGBCL) 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.

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Agent

experimental: Combination Treatment

Interventions

TLN-121

Specified dose on specified days.

zeprumetostat (TLN-254)

Specified dose on specified days.

TLN-121

Specified dose on specified days.

Primary outcome measure

  • Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254. [ Time Frame: Up to 2 years ]
  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) [ Time Frame: Up to 2 years ]
  • Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 [ Time Frame: Up to 2 years ]
  • Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Stanford Medicine Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

The START Center for Cancer Care - Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Steven Horwitz

horwitzs@mskcc.org

Weill Cornell Medicine - New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Principal Investigator

lsehn@bccancer.bc.ca

More Information

Sponsor

Treeline Biosciences, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Relapsed or Refractory Non-Hodgkin Lymphomas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Treeline Biosciences, Inc. on 2026-09-04.