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This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma

NCT07121946 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-10

No results posted yet for this study

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

Conditions

  • Non-Hodgkin Lymphoma Refractory/ Relapsed
  • DLBCL - Diffuse Large B Cell Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Follicular Lymphoma ( FL)
  • Marginal Zone Lymphoma (MZL)

Interventions

BIOLOGICAL

LTZ-301

LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks.

BIOLOGICAL

LTZ-301

LTZ-301will be dosed IV, as above

BIOLOGICAL

LTZ-301

LTZ-301will be dosed IV, as above

Sponsors & Collaborators

  • LTZ Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121946 on ClinicalTrials.gov