NCT07082803

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
54mo left

Started Jun 2025

Typical duration for phase_1 lymphoma

Geographic Reach
3 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2025Nov 2030

Study Start

First participant enrolled

June 23, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

June 26, 2025

Last Update Submit

March 25, 2026

Conditions

LymphomaLymphoma, Non Hodgkin

Keywords

Relapsed or Refractory Non-Hodgkin Lymphomas

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to 2 years

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)

    Up to 2 years

  • Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

    Up to 2 years

  • Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

    Up to 2 years

Secondary Outcomes (7)

  • Maximum Observed Plasma Concentration (Cmax) of TLN-121

    Up to 2 years

  • Time to Maximum Plasma Concentration (Tmax) of TLN-121

    Up to 2 years

  • Minimum Observed Plasma Concentration (Cmin) of TLN-121

    Up to 2 years

  • Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121

    Up to 2 years

  • Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the objective response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma

    Up to 2 years

  • +2 more secondary outcomes

Study Arms (2)

Single Agent

EXPERIMENTAL
Drug: TLN-121

Combination Treatment

EXPERIMENTAL
Drug: TLN-254Drug: TLN-121

Interventions

TLN-121DRUG

Specified dose on specified days.

Single Agent
TLN-254DRUG

Specified dose on specified days.

Combination Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Disease Characteristics
  • Participant must have measurable disease at study entry
  • Participants must have one of the following histologically documented hematologic malignancies:
  • 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.
  • FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.
  • 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.
  • High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2 prior systemic treatment regimens.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
  • 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.
  • Pregnant or lactating.
  • Conditions that could affect drug absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Stanford Medicine Cancer Center

Palo Alto, California, 94304, United States

RECRUITING

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Cabrini Health

Malvern, Victoria, 3144, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Treeline Clinical Operations

CONTACT

857-228-0050clinicaloperations@treeline.bio

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 24, 2025

Study Start

June 23, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(6)AU(5)CA(1)