TLN-121 + TLN-254 for Non-Hodgkin's Lymphoma

Recruiting at 9 trial locations

Overseen By Elizabeth Webber

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Treeline Biosciences, Inc.

Disqualifiers: CNS involvement, Recent stem cell transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TLN-121 for individuals with certain types of Non-Hodgkin's Lymphoma, a cancer of the lymphatic system. The study aims to determine the safety and efficacy of TLN-121, both alone and in combination with other treatments. It is open to those with specific types of lymphoma, such as diffuse large B-cell lymphoma or follicular lymphoma, that have returned or not improved after at least one or two treatments. Participants should have measurable disease symptoms and be healthy enough to perform daily activities without major limitations. As a Phase 1 trial, this research focuses on understanding how TLN-121 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that TLN-121 is likely to be safe for humans?

Research has shown that TLN-121, both alone and with TLN-254, is undergoing testing for safety in individuals with relapsed or hard-to-treat Non-Hodgkin's Lymphoma. These early-stage tests primarily assess treatment tolerance. Although specific data from these studies is not yet available, early trials closely monitor side effects and patient responses. TLN-121 targets a protein in cancer cells, aiming to protect healthy cells as much as possible. This approach suggests a focus on reducing side effects, with detailed safety results to be released as the study progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TLN-121 for Non-Hodgkin's Lymphoma because it offers a fresh approach compared to traditional treatments like chemotherapy and radiation. Unlike these standard options, which often target healthy as well as cancerous cells, TLN-121 is designed to specifically target and disrupt cancer cell pathways, potentially leading to fewer side effects. Additionally, when combined with TLN-254, the treatment aims to enhance the immune system's ability to fight cancer cells, offering a dual-action strategy that could improve patient outcomes. This targeted and immune-boosting approach presents a promising alternative to existing therapies.

What evidence suggests that TLN-121 might be an effective treatment for Non-Hodgkin's Lymphoma?

In this trial, participants will receive either TLN-121 alone or in combination with TLN-254 to treat Non-Hodgkin's Lymphoma (NHL), a cancer affecting the lymphatic system. Research has shown that TLN-121 targets and breaks down a protein called BCL6, which helps some cancer cells survive. By removing BCL6, TLN-121 aims to stop cancer cell growth. The combination treatment includes TLN-254, which blocks EZH2, another protein that aids tumor growth. Together, these drugs could be more effective against NHL. Early results suggest this approach might benefit patients whose cancer has returned or not responded to other treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Non-Hodgkin Lymphomas that have come back or didn't respond to previous treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to fit specific lymphoma subtypes.

Inclusion Criteria

My cancer can be measured by tests or scans.

My cancer is a specific type of blood cancer confirmed by lab tests.

I am fully active or can carry out light work.

Exclusion Criteria

Pregnant or lactating

I have never had cancer spread to my brain or spinal cord.

Participants must not have any condition that places them at unacceptable risk if participating in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TLN-121 as a single agent or in combination with other anti-lymphoma therapies

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TLN-121

Trial Overview The study is testing TLN-121 alone and in combination with other anti-lymphoma drugs to assess safety, how the body processes it, and its initial effectiveness against relapsed or refractory Non-Hodgkin Lymphomas.

How Is the Trial Designed?

Group I: Single Agent Experimental Treatment 1 Intervention

Group II: Combination Treatment Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Treeline Biosciences, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07082803

NCT07082803 | TLN-121 in Relapsed or Refractory Non- ... ... TLN-121 alone or in combination with TLN-254. Up to 2 years. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related ...

2. withpower.com withpower.com/trial/phase-1-lymphoma-5-2025-d10df

TLN-121 + TLN-254 for Non-Hodgkin's Lymphoma 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 ...

3. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-of-tln-121-in-participants-with-relapsed-or-refractory-non-hodgkin-lymphomas

A drug, TLN-121, alone and in combination with TLN-254 ... If TLN-121, alone and in combination with TLN-254, is safe and works well to treat NHL that has relapsed or is refractory.

4. treeline.bio treeline.bio/press/treeline-announces-first-clinical-trials-and-secures-usd200m-in-additional-funding

Treeline Announces First Clinical Trials and Secures $200M ... TLN-121 is a protein degrader designed to remove BCL6 from cancer cells while avoiding off-target effects that could cause toxicity, potentially ...

5. synapse.patsnap.com synapse.patsnap.com/drug/c8b80c3abc7f44878790be91f5fc8079

TLN-254 - Drug Targets, Indications, Patents Treeline has launched phase 1 lymphoma trials for a BCL6 degrader called TLN-121 and an EZH2 inhibitor called TLN-254, according to the Sept. 3 ...

6. synapse.patsnap.com synapse.patsnap.com/drug/f4b35256cd2d43fea5f24183e03bb4fa

TLN-121 - Drug Targets, Indications, Patents An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and ...

7. australianclinicaltrials.gov.au australianclinicaltrials.gov.au/anzctr-search-results?condition_category=all&condition_code=all&ethics_approval=No&gender=all&healthy_volunteers=all&phase=all&purpose_of_study=all&recruitment_sites=all&recruitment_status=all&search_text=&page=185

ANZCTR search results | Australian Clinical ... 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 ...