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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion
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
Emory Winship Cancer Institute
Atlanta, Georgia, United States
NYU Langone Health
New York, New York, United States
Levine Cancer Institute, Atrium Health
Charlotte, North Carolina, United States
Part 1 & Part 2 - Frequency and severity of AEs:
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.
Time frame: Approximately 6 months
Part 1 - Frequency and type of DLT
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
Time frame: First 28 days of treatment
Part 1 & Part 2: Number of participants with an antitumor response
Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria
Time frame: Approximately 6 months
Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051
Time frame: Approximately 6 months
Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies
Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated
Time frame: Approximately 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
CHU Lille
Lille, France
University Hospital of Nantes
Nantes, France
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
...and 4 more locations