TLN-254 for Lymphoma

Recruiting at 5 trial locations

Overseen By Treeline Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Treeline Biosciences, Inc.

Disqualifiers: CNS involvement, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

50 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-254, a potential drug for T-cell lymphoma, a type of blood cancer, when other treatments have failed. The study targets individuals whose cancer has returned or not responded to previous treatments. Participants are divided into two groups: one for peripheral T-cell lymphoma and another for cutaneous T-cell lymphoma. Eligible participants must have this type of lymphoma, have tried other treatments, and show visible signs of the disease. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must not have had any systemic anti-cancer treatment within 4 weeks before starting the study.

Is there any evidence suggesting that TLN-254 is likely to be safe for humans?

Research has shown that TLN-254 is being tested for safety in people with T-cell lymphoma. This is a Phase 1 trial, meaning doctors primarily assess the treatment's safety for humans. They aim to determine the highest dose patients can tolerate without serious side effects.

Limited information exists on TLN-254's safety in humans, but this phase focuses on closely monitoring how patients handle the treatment. Phase 1 trials typically involve a small group of people, allowing researchers to observe any immediate health effects.

Prospective participants should know that the team will monitor for side effects to ensure safety. They will adjust doses based on participants' reactions to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TLN-254 for lymphoma because it offers a novel approach compared to standard treatments like chemotherapy and radiation. Unlike these traditional methods that often affect both healthy and cancerous cells, TLN-254 targets specific pathways involved in lymphoma cell survival and growth, potentially reducing side effects. This targeted mechanism could lead to more effective treatment outcomes, making TLN-254 an exciting development in the fight against lymphoma.

What evidence suggests that TLN-254 might be an effective treatment for lymphoma?

Research is investigating TLN-254 as a potential treatment for T-cell lymphoma. This drug blocks EZH2, an enzyme that can promote cancer growth. Early studies have shown that inhibiting EZH2 might slow or halt tumor growth in some cancers, such as lymphoma. Although human data on TLN-254 remains limited, its interaction with cancer cells appears promising. The current trial includes two separate cohorts, each receiving TLN-254 as a single agent, to determine if it can shrink tumors in patients whose lymphoma has recurred or resisted other treatments. The primary goal is to gather early evidence of its effectiveness against tumors. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with T-cell lymphoma that has returned or hasn't responded to previous treatments. Specific details about who can join are not provided, but typically participants need to meet certain health standards and have a confirmed diagnosis.

Inclusion Criteria

My cancer can be measured by tests or scans.

I have a recent or stored tissue sample available.

My PTCL has not improved after at least one treatment. I've had brentuximab for my ALCL.

Exclusion Criteria

I haven't had cancer treatment, a donor stem cell transplant in the last 90 days, or my own stem cell transplant in the last 60 days.

I have or had brain or spinal cord involvement.

I cannot swallow pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TLN-254 monotherapy to evaluate anti-tumor activity

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TLN-254

Trial Overview The study is testing the effectiveness of a single drug treatment called TLN-254 on its own (monotherapy) in patients whose T-cell lymphoma has either come back after treatment or did not respond to prior therapies.

How Is the Trial Designed?

Group I: Cohort 2: TLN-254 Single Agent Experimental Treatment 1 Intervention

Group II: Cohort 1: TLN-254 Single Agent Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Treeline Biosciences, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

The 2022 International Consensus Classification has updated the classification of nodal T- and NK-cell lymphomas, grouping T-follicular helper cell lymphomas into a single entity with three subtypes, which reflects their shared origin and characteristics.

A new provisional entity, primary nodal EBV-positive T-/NK-cell lymphoma, has been introduced, highlighting the evolving understanding of these malignancies and the need for precise diagnostic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classification and diagnostic evaluation of nodal T- and NK-cell lymphomas. Feldman, AL., Laurent, C., Narbaitz, M., et al.[2023]

In a large phase II study involving 166 patients with untreated systemic peripheral T-cell lymphomas (PTCL), a dose-dense induction therapy followed by high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) resulted in a 5-year overall survival rate of 51% and a progression-free survival rate of 44%.

The treatment was well tolerated, with a low treatment-related mortality rate of 4%, indicating that this approach is a promising option for patients with PTCL, especially given the advanced age and high-risk profile of the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. d'Amore, F., Relander, T., Lauritzsen, GF., et al.[2022]

High-dose therapy followed by autologous stem cell transplantation (HDT-autoSCT) shows good feasibility and low toxicity for treating peripheral T/NK-cell lymphomas (PTCLs), which are rare and have poor prognosis.

Achieving complete remission before transplantation is the most important factor for improving patient outcomes, and a new randomized trial will compare HDT-autoSCT with allogeneic stem cell transplantation (alloSCT) to better define treatment roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of autologous and allogeneic stem cell transplantation in peripheral T-cell lymphomas. Reimer, P.[2021]

Adult T-cell leukemia-lymphoma (ATL), the most common T-/NK cell lymphoma in Japan, is linked to the human T-cell lymphotropic virus type I (HTLV-1), prompting extensive clinical research.

Current clinical trials are exploring various treatment options for ATL, including an anti-CCR4 antibody, forodesine, and lenalidomide, with additional discussions on pralatrexate and denileukin diftitox for ATL and peripheral T-cell lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials for human T-cell lymphotropic virus type I-associated peripheral T-cell lymphoma in Japan. Tobinai, K.[2018]

Peripheral T/NK-cell lymphomas (PTCL) are rare and have a worse prognosis compared to B-cell lymphomas, with standard treatments yielding long-term remissions in only 15-42% of patients.

High-dosage therapy with autologous stem cell transplantation (autoSCT) shows similar outcomes to aggressive B-cell lymphomas for relapsing PTCL, suggesting it may be a viable salvage option, but the effectiveness of newer treatments remains uncertain, highlighting the need for clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peripheral T-cell lymphoma: diagnosis and treatment]. Reimer, P., Hentrich, M.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06733441

NCT06733441 | A Study of TLN-254 in Participants With ... The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

2. withpower.com withpower.com/trial/phase-1-lymphoma-11-2024-c7c56

TLN-254 for Lymphoma · Recruiting Participants for Phase ... The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.

3. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-of-tln-254-in-participants-with-relapsed-or-refractory-t-cell-lymphoma

A drug, TLN-254, to treat T-cell lymphoma that has come ... The clinical trial doctors will check your health for up to 2 years. The Food and Drug Administration (FDA) has not yet approved TLN-254.

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07082803

NCT07082803 | TLN-121 in Relapsed or Refractory Non- ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.