TLN-121 for relapsed or refractory non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial led by Treeline Biosciences that gives TLN-121 as a single agent and in combination with other anti-lymphoma therapies to people with relapsed or refractory non-Hodgkin lymphomas. The primary aims are to collect safety data, measure how the drug behaves in the body (pharmacokinetics), and look for early signs of anti-tumor activity. Eligible patients must have measurable disease and specific lymphoma subtypes such as DLBCL, certain grades of follicular lymphoma, transformed lymphoma, or select peripheral T-cell lymphoma subtypes after prior therapies. Procedures and treatments are delivered at participating cancer centers in California, Michigan, and Missouri.

Why it matters

Who can join: the full rules

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. Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBLC), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, transformed lymphoma from FL, or High-Grade B-Cell lymphoma (HGBCL) 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 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.

Where it's running

• Stanford Medicine Cancer Center
  Palo Alto, California, United States Recruiting
• The START Center for Cancer Care - Midwest
  Grand Rapids, Michigan, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Weill Cornell Medicine - New York Presbyterian Hospital
  New York, New York, United States Recruiting
• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Treeline Clinical Operations
• Email: clinicaloperations@treeline.bio
• Phone: 857-228-0050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.