Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Multiple Myeloma
Acute Myeloid Leukemia

Brief Summary: A phase 1/2a, 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 1/2a 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
LAVA-051	LAVA-051	Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection. * Group A: LAVA-051 * Group B: LAVA-051 + low dose interleukin 2 Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study
LAVA-051	Interleukin 2	Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection. * Group A: LAVA-051 * Group B: LAVA-051 + low dose interleukin 2 Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study

Primary Outcome Measures

Name	Time	Method
Part 1 & Part 2 - Frequency and severity of AEs:	Approximately 6 months	Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.
Part 1 - Frequency and type of DLT	First 28 days of treatment	A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria

Secondary Outcome Measures

Name	Time	Method
Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)	Approximately 6 months	Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051
Part 1 & Part 2: Number of participants with an antitumor response	Approximately 6 months	Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria
Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies	Approximately 6 months	Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated

Locations (14): Emory Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
NYU Langone Health
🇺🇸
New York, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Levine Cancer Institute, Atrium Health
🇺🇸
Charlotte, North Carolina, United States
CHU Lille
🇫🇷
Lille, France
Amsterdam UMC, location VUmc
🇳🇱
Amsterdam, Noord-Holland, Netherlands
Erasmus MC
🇳🇱
Rotterdam, Zuid-Holland, Netherlands
Cima University of Navarra
🇪🇸
Madrid, Spain
University Hospital Vall d'Hebron
🇪🇸
Barcelona, Spain
Clinica Universida de Navarra
🇪🇸
Pamplona, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸
Salamanca, Spain
University Hospital of Nantes
🇫🇷
Nantes, France
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Amsterdam UMC, location AMC
🇳🇱
Amsterdam, Noord Holland, Netherlands