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

Phase 1

Recruiting

• Conditions: Lymphoma
• Interventions: Drug: TLN-254

• Registration Number: NCT06733441
• Lead Sponsor: Treeline Biosciences, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Study Start: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-11-15
• Study Completion: 2028-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: TLN-254 Single Agent	TLN-254	-
Cohort 2: TLN-254 Single Agent	TLN-254	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With CR	Up to 2 years
Percentage of Participants With Objective Response	Up to 2 years
Percentage of Participants With PR	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 2 years
Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0	Up to 2 years
Plasma concentrations of TLN-254	Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)
Duration of Response (DOR)	Up to 2 years

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States