Clinical trial · Interventional
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and in Combination With Other Anti-Lymphoma Agents, in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas
NCT07082803CI-TRIAL-00126035recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Non Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TLN-121 | Drug | — | UNRESOLVED |
| zeprumetostat (TLN-254) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single Agent
- interventionNames
- Drug: TLN-121
- type
- EXPERIMENTAL
- label
- Combination Treatment
- interventionNames
- Drug: zeprumetostat (TLN-254)
- Drug: TLN-121
Primary outcomes (4)
- measure
- Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254.
- timeFrame
- Up to 2 years
- measure
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBLC), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, transformed lymphoma from FL, or High-Grade B-Cell lymphoma (HGBCL) 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 central nervous system (CNS) involvement. Participants with past history of CNS involvement of lymphoma must have had CNS disease fully treated with no evidence of recurrence within 12 months.
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.References
Publications (0)
Data not yet available
No reference posted for this study.