NCT07121946 This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma
| NCT ID | NCT07121946 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | LTZ Therapeutics, Inc. |
| Condition | Non-Hodgkin Lymphoma Refractory/ Relapsed |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-01-29 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07121946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Hodgkin Lymphoma Refractory/ Relapsed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07121946 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07121946 currently recruiting?
Yes, NCT07121946 is actively recruiting participants. Contact the research team at sherry.unabia@ltztherapeutics.com for enrollment information.
Where is the NCT07121946 trial being conducted?
This trial is being conducted at Duarte, United States, St Louis, United States, Buffalo, United States, Nashville, United States and 1 additional location.
Who is sponsoring the NCT07121946 clinical trial?
NCT07121946 is sponsored by LTZ Therapeutics, Inc.. The trial plans to enroll 42 participants.