TLN-254 for Lymphoma

Recruiting at 1 trial location

Overseen By Catherine Maccaro, BS

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

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug TLN-254 unique for treating lymphoma?

The research does not provide specific information about TLN-254, so its unique aspects compared to other lymphoma treatments are not clear from the available data. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Classification and diagnostic evaluation of nodal T- and NK-cell lymphomas. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

[Peripheral T-cell lymphoma: diagnosis and treatment]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. [2022]