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

LTZ Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Marginal Zone Lymphoma (MZL)

Follicular Lymphoma ( FL)

Mantle Cell Lymphoma (MCL)

DLBCL - Diffuse Large B Cell Lymphoma

Non-Hodgkin Lymphoma Refractory/ Relapsed

Treatments

Biological: LTZ-301

Study type

Interventional

Funder types

Industry

Identifiers

NCT07121946

LTZ-301-001

Details and patient eligibility

About

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

Full description

LTZ-301 is a bispecific antibody which is a Myeloid cell engager, which targets B-cells via CD79B, and triggers phagocytosis

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

42 participants in 3 patient groups

Dose Escalation

Experimental group

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.

Treatment:

Biological: LTZ-301

Backfill Expansion

Experimental group

Description:

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

Treatment:

Biological: LTZ-301

Expansion

Experimental group

Description:

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