A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission

CSL Limited30 enrolled

Overview

This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Acute

Interventions

CSL362BIOLOGICAL

CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Rα; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells. CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18 years or older. * Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary. * Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (CR)/CR with incomplete platelet recovery (CRp); either first or second CR. * Has factors conferring high risk of relapse. * No plans for additional post-remission chemotherapy. * Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT). Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia (APL). * Known leukemic involvement of the central nervous system. * Life expectancy 4 months or less as estimated by the investigator. * Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).

Locations (5)

Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School

Chicago, Illinois, United States

Sidney Kimmel Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Weill Cornell Medical College

New York, New York, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Outcomes

Primary Outcomes

Frequency and Severity of Adverse Events (AEs)

Number of subjects reporting any AEs and the severity of those AEs.

Time frame: From the first treatment (Day 1) up to approximately Day 106

Dose-limiting toxicity (DLT) evaluation

Number of participants with DLT. Dose-limiting toxicity (DLT) is defined as: * A non-hematological toxicity grade 3 or worse. * A hematological toxicity grade 3 that does not recover to baseline within 14 days. * A hematological toxicity grade 4 or worse according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.

Time frame: From the first treatment (Day 1) up to approximately Day 106

Secondary Outcomes

Pharmacokinetic (PK) Parameters

PK Parameters comprise: * Area under the serum concentration time curve (AUC) from time point zero (before dosing): * to the time point at which the analyte first returns to baseline (AUC0-last) * to a meaningful time after infusion (AUC0-y) * extrapolated to infinity (AUC0-∞). * The maximum observed serum concentration (Cmax). * First time to reach maximum concentration in serum (Tmax). * Terminal serum half-life (t 1/2)

Time frame: Before each infusion and: at 6 time points within a week after infusion 1, at 1 time point within a week after infusions 2 to 5, at 5 time points within a week after infusion 6, and once at the final visit, approximately 5 weeks after infusion 6

Number of subjects developing antibodies against CSL362

Time frame: From the first treatment (Day 1) up to approximately Day 106

Data from ClinicalTrials.gov

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