RecruitingRecruiting
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
NCT07082803 · Treeline Biosciences, Inc.
In plain English
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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
About this study
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
Eligibility criteria
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.
Study design
Enrollment target: 180 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-23
Estimated completion: 2030-11
Last updated: 2026-03-27
Interventions
Drug: TLN-121Drug: TLN-254Drug: TLN-121
Primary outcomes
- • 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)
Sponsor
Treeline Biosciences, Inc. · industry
Contacts & investigators
ContactTreeline Clinical Operations · contact · clinicaloperations@treeline.bio · 857-228-0050
All locations (12)
Stanford Medicine Cancer CenterRecruiting
Palo Alto, California, United States
The START Center for Cancer Care - MidwestRecruiting
Grand Rapids, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Macquarie University HospitalRecruiting
Macquarie Park, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Cabrini HealthRecruiting
Malvern, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Perth, Western Australia, Australia
BC Cancer - VancouverRecruiting
Vancouver, British Columbia, Canada