NCT04887259

Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML

A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients with Relapsed or Refractory CLL, MM, or AML

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lava Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 1, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).

Detailed description

An open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML. The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Conditions

• Chronic Lymphocytic Leukemia
• Multiple Myeloma
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	LAVA-051	In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion
BIOLOGICAL	Interleukin 2	In Part 1 and Part 2, a low dose of interleukin 2 will be given via subcutaneous injection with LAVA-051 in a selected group of patients

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2021-05-14
• Last updated: 2025-01-27

Locations

14 sites across 4 countries: United States, France, Netherlands, Spain

Regulatory

• FDA-regulated drug study