NCT07121946

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
21mo left

Started Jan 2026

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Feb 2028

First Submitted

Initial submission to the registry

August 12, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

August 12, 2025

Last Update Submit

February 6, 2026

Conditions

Non-Hodgkin Lymphoma Refractory/ RelapsedDLBCL - Diffuse Large B Cell LymphomaMantle Cell Lymphoma (MCL)Follicular Lymphoma ( FL)Marginal Zone Lymphoma (MZL)

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    To determine the incidence of adverse events according to CTCAE v5.0 and meeting protocol defined and dose limiting toxicity criteria.

    Up to 54 weeks

Study Arms (3)

Dose Escalation

EXPERIMENTAL

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.

Biological: LTZ-301

Backfill Expansion

EXPERIMENTAL

Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.

Biological: LTZ-301

Expansion

EXPERIMENTAL

A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.

Biological: LTZ-301

Interventions

LTZ-301BIOLOGICAL

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.

Dose Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, FollicularLymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Central Study Contacts

Sherry Unabia

CONTACT

669-207-0084sherry.unabia@ltztherapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 14, 2025

Study Start

January 29, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

February 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)