RecruitingPhase 1NCT06733441

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

Phase 1b, Randomized, Dose Optimization Study to Assess the Anti-Tumor Activity, Safety, and Pharmacokinetics of TLN-254 in Patients With Relapsed or Refractory T-cell Lymphoma

Sponsor

Treeline Biosciences, Inc.

Enrollment

50 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria20

Age:
At least 18 years of age at the time of signing the informed consent form (ICF).
Type of Participant and Disease Characteristics:
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
Participant must have measurable disease at study entry.
Freshly biopsied or archival tissue available.
Diagnostic Assessments:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Adequate organ function.
Contraception:
Participants must accept and follow the pregnancy prevention plan.

Exclusion Criteria7

Medical Conditions:
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.
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.
Current or past history of central nervous system (CNS) involvement.
Other Exclusions:
Pregnant or lactating women.
Unable to swallow tablets.