TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

NCT07082803
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
180
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Lead sponsor
Treeline Biosciences, Inc.
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Start date
2025-06-23
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Number of sites
14
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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
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Short title
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-11-01
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First posted
2025-07-24
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Registry last updated
2026-07-20
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Primary completion date
2030-09-01
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Start date
2025-06-23
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Participants
180
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Participant count basis
Estimated
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Planned participants
180
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Protocol amendments
1
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Treeline Biosciences, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07082803
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ClinicalTrials.gov ID
NCT07082803
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. 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.

    Timeframe: Up to 2 years

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

    Timeframe: Up to 2 years

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

    Timeframe: Up to 2 years

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

    Timeframe: Up to 2 years

  1. Maximum Observed Plasma Concentration (Cmax) of TLN-121

    Timeframe: Up to 2 years

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

    Timeframe: Up to 2 years

  3. Minimum Observed Plasma Concentration (Cmin) of TLN-121

    Timeframe: Up to 2 years

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

    Timeframe: Up to 2 years

  5. 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

    Timeframe: Up to 2 years

  6. 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

    Timeframe: Up to 2 years.

  7. 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

    Timeframe: Up to 2 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

  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.
Sources for eligibility
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  • Stanford Medicine Cancer CenterPalo Alto, United StatesRecruiting
  • The START Center for Cancer Care - MidwestGrand Rapids, United StatesRecruiting
  • Washington University School of MedicineSt Louis, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Weill Cornell Medicine - New York Presbyterian HospitalNew York, United StatesRecruiting
  • Hospital of the University of PennsylvaniaPhiladelphia, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Macquarie University HospitalMacquarie Park, AustraliaRecruiting
  • Princess Alexandra HospitalWoolloongabba, AustraliaRecruiting
  • Cabrini HealthMalvern, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • Linear Clinical ResearchPerth, AustraliaRecruiting
  • BC Cancer - VancouverVancouver, CanadaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)