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RecruitingInterventionalPhase 1

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

NCT ID: NCT07082803Sponsor: Treeline Biosciences, Inc.Last updated: 2026-03-27

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

Arms & interventions

  • DrugTLN-121

    Specified dose on specified days.

  • DrugTLN-254

    Specified dose on specified days.

  • DrugTLN-121

    Specified dose on specified days.

Outcome measures

Primary

  • 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

Secondary

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (6)

Stanford Medicine Cancer Center

Palo Alto, California, 94304

Recruiting

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, 49546

Recruiting

Washington University School of Medicine

St Louis, Missouri, 63108

Recruiting
Amalia Dubois · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Steven Horwitz · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting
Principal Investigator · Contact

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Dai Chihara, Dr. · Contact