Recruiting
Phase 1

LTZ-301

Sponsor:

LTZ Therapeutics, Inc.

Code:

NCT07121946

Conditions

Non-Hodgkin Lymphoma Refractory/ Relapsed

DLBCL - Diffuse Large B Cell Lymphoma

Mantle Cell Lymphoma (MCL)

Follicular Lymphoma ( FL)

Marginal Zone Lymphoma (MZL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LTZ-301

LTZ-301

LTZ-301

Study Details

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

Conditions

Non-Hodgkin Lymphoma Refractory/ Relapsed

DLBCL - Diffuse Large B Cell Lymphoma

Mantle Cell Lymphoma (MCL)

Follicular Lymphoma ( FL)

Marginal Zone Lymphoma (MZL)

Study ID

NCT07121946

Start date

Jan 29, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

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.

experimental: Backfill Expansion

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

experimental: Expansion

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

Interventions

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.

LTZ-301

LTZ-301will be dosed IV, as above

LTZ-301

LTZ-301will be dosed IV, as above

Primary outcome measure

  • Safety and Tolerability [ Time Frame: Up to 54 weeks ]

Central Contacts and Locations

Central contacts

Sherry Unabia

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

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Elizabeth Budde, MD

626-218-2405ebudde@coh.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Anne Fischer

314-362-3021afischer@wustl.edu

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Francisco Hernandez, MD

716-845-2300Francisco.Hernandez@RoswellPark.org

Memorial Sloan Kettering Cancer Center - Bergen

Recruiting

New York, New York, United States, 10065

Contacts

Pallawi Torka, MD

201-775-7808torkap@mskcc.org

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Michael Byrne, DO

888-550-2835mbyrne@tnonc.com

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Ajay Gopal, MD

206-606-2037agopal@uw.edu

More Information

Sponsor

LTZ Therapeutics, Inc.

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by LTZ Therapeutics, Inc. on 2026-07-24.