TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

Treeline Biosciences, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Lymphoma; Lymphoma, Non Hodgkin

Treatments: Drug: TLN-254; Drug: TLN-121

Study type: Interventional

Funder types: Industry

Identifiers

NCT07082803

TLN-121-2501

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Disease Characteristics

1. Participant must have measurable disease at study entry

2. Participants must have one of the following histologically documented hematologic malignancies:

   1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following at least 2 prior lines of therapy.

   2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.

   3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen:

      • Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
      • Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
      • Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

1. Participants must not have current or past history of central nervous system (CNS) involvement.
2. Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study.
3. Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study.
4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
5. 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.
6. Pregnant or lactating.
7. Conditions that could affect drug absorption.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Single Agent

Experimental group

Treatment:

Drug: TLN-121

Drug: TLN-121

Combination Treatment

Experimental group

Treatment:

Drug: TLN-121

Drug: TLN-254

Drug: TLN-121