TLN-121 for relapsed or refractory non-Hodgkin lymphoma

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

We will test TLN-121 by itself and together with other lymphoma treatments in people whose non-Hodgkin lymphoma has returned or did not respond to prior therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Treeline Biosciences, Inc. (Industry-sponsored)
• Drugs / interventions: CAR T
• Locations: 12 sites (Palo Alto, California and 11 other locations)
• Trial ID: NCT07082803 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with measurable relapsed or refractory non-Hodgkin lymphoma of specified subtypes (including DLBCL, certain grades of follicular lymphoma, transformed lymphoma, and listed PTCL subtypes) who have received the required number of prior therapies as detailed in the inclusion criteria.

Not a fit: Patients without measurable disease, those with lymphoma subtypes not listed in the eligibility criteria, or those who are medically unable to tolerate an experimental therapy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If TLN-121 proves safe and active, it could become a new treatment option for people with relapsed or refractory non-Hodgkin lymphoma, either alone or in combination with existing therapies.

How similar studies have performed: Other early-phase targeted and combination approaches in relapsed/refractory non-Hodgkin lymphoma have shown promise, but TLN-121 itself is investigational and its effects have not yet been established.

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.

Where this trial is running

Palo Alto, California and 11 other locations

• 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)
• SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Macquarie University Hospital — Macquarie Park, New South Wales, Australia (Recruiting)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
• Cabrini Health — Malvern, Victoria, Australia (Recruiting)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
• Linear Clinical Research — Perth, Western Australia, Australia (Recruiting)
• BC Cancer - Vancouver — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Study coordinator: Treeline Clinical Operations

Conditions Lymphoma; Lymphoma, Non Hodgkin; Relapsed or Refractory Non-Hodgkin Lymphomas