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RecruitingLast updated: 18 September 2025

A study testing a new drug (TLN-121) alone and in combination with other anti-lymphoma therapies for relapsed or refractory Non-Hodgkin LymphomasAn 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Clinical summary

Summary

This study evaluates the effectiveness of a drug called TLN-121 when administered alone and in combination with other anti-lymphoma therapies in people with relapsed or refractory Non-Hodgkin Lymphomas. 

You may be eligible if you have diffuse large B-cell lymphoma (DLBCL, NOS), follicular lymphoma, or peripheral T-cell lymphoma (PTCL).

Eligible participants will be allocated into one of two treatment arms. One arm will receive schedules doses of TLN-121 on given days while the other arm will receive scheduled doses of TLN-121 and TLN-254 on scheduled days. 

To be eligible you must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study, or an autologous stem cell transplantation within 90 days prior to the start of the study. 

 

Conditions

This trial is treating people with relapsed or refractory Non-Hodgkin Lymphomas.

Eligibility

Inclusion

  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

 

  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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Treeline Biosciences, Inc.

Scientific 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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