TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

Not Applicable

Recruiting

• Conditions: Lymphoma; Lymphoma, Non Hodgkin
• Interventions: Drug: TLN-121; Drug: TLN-254

• Registration Number: NCT07082803
• Lead Sponsor: Treeline Biosciences, Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-23
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-07-16
• Study First Posted: 2025-07-24
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Primary Completion: 2030-09
• Study Completion: 2030-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Agent	TLN-121	-
Combination Treatment	TLN-254	-
Combination Treatment	TLN-121	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression	Up to 2 years
Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the complete response rate (CR) according to the Lugano response criteria for Non-Hodgkin Lymphoma	Up to 2 years.

Trial Locations

Locations (7)

Macquarie University Hospital; 🇦🇺 Macquarie Park, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Cabrini Health; 🇦🇺 Malvern, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

The START Center for Cancer Care - Midwest; 🇺🇸 Grand Rapids, Michigan, United States

Linear Clinical Research; 🇦🇺 Perth, Western Australia, Australia