A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma

NCT ID: NCT06733441

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2028-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: TLN-254 Single Agent

Group Type EXPERIMENTAL

TLN-254

Intervention Type DRUG

TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.

Cohort 2: TLN-254 Single Agent

Group Type EXPERIMENTAL

TLN-254

Intervention Type DRUG

TLN-254 will be administered orally at a specified dose on specified days.

Interventions

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TLN-254

TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.

Intervention Type DRUG

TLN-254

TLN-254 will be administered orally at a specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Age:

1. At least 18 years of age at the time of signing the informed consent form (ICF).

Type of Participant and Disease Characteristics:
2. Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment.

* Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
* Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
* Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS.
* PTCL, NOS.
* Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive.
* Anaplastic large-cell lymphoma, ALK negative.

Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
* Sezary syndrome
* Mycosis fungoides
3. Participant must have measurable disease at study entry.
4. Freshly biopsied or archival tissue available.

Diagnostic Assessments:
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
6. Adequate organ function.

Contraception:
7. Participants must accept and follow the pregnancy prevention plan.

Exclusion Criteria

Medical Conditions:

1. Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation.
2. 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.
3. Current or past history of central nervous system (CNS) involvement.

Other Exclusions:

* Pregnant or lactating women.
* Unable to swallow tablets.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Treeline Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford Cancer Institute

Stanford, California, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Treeline Clinical Operations

Role: CONTACT

857-228-0050

Facility Contacts

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Nana Shakhnazaryan

Role: primary

650-304-9443

Molly Dubois, Sr. Clinical Research Coordinator

Role: primary

314-273-1486

Catherine Maccaro

Role: primary

646-608-2883

AskSarah Help Line

Role: primary

844-482-4812

Kerry Savage

Role: primary

604-877-6000 ext. 672295

Other Identifiers

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TLN-254-2401

Identifier Type: -

Identifier Source: org_study_id

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