Clinical trial · Interventional
This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
NCT07121946CI-TRIAL-00119238recruitingPhase 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)
This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | — | UNRESOLVED | — |
| Follicular Lymphoma ( FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone Lymphoma (MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Non-Hodgkin Lymphoma Refractory/ Relapsed | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LTZ-301 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously.
- interventionNames
- Biological: LTZ-301
- type
- EXPERIMENTAL
- label
- Backfill Expansion
- description
- Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.
- interventionNames
- Biological: LTZ-301
- type
- EXPERIMENTAL
- label
- Expansion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Relapsed or refractory to at least 2 prior systemic treatment regimens * At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function Exclusion Criteria: * CLL, or Richters transformation * Prior solid organ transplant * Prior allogeneic stem cell transplant * ASCT within 100 days prior to the first LTZ-301 administration * Prior CAR-T within 60 days prior to the first LTZ-301 administration * Current central nervous system (CNS) lymphoma * Known history of human immunodeficiency virus (HIV) seropositivity * Active autoimmune disease * History of clinically significant cardiovascular disease * symptomatic deep vein thrombosis (DVT) within 3 months of enrollment * History of other malignancy within 3 years prior to screening
References
Publications (0)
Data not yet available
No reference posted for this study.