NCT03591614

Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma

A Pilot Study of Dendritic Cell DKK1 Vaccine for Patients With Monoclonal Gammopathy and Stable or Smoldering Myeloma

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study the safety and preliminary efficacy of a dendritic cell DKK1 vaccine against myeloma. Dendritic cells are immune cells that are collected from the blood of the patient at Case Western Reserve Medical Center and then brought into contact with DKK1, a molecule that is present of myeloma cells but not to a significant amount on other cells except for the prostate and the placenta. It is an investigational (experimental) vaccine that based on studies in the laboratory and in mice is expected to work by presentation of DKK1 to anticancer immune cells via dendritic cells leading to an immune attack on myeloma cells. It is experimental because it is not approved by the Food and Drug Administration (FDA).

Detailed description

The overall objective of this pilot study is to determine the safety and preliminary efficacy of a dendritic cell DKK1 vaccine in view of possible future use as a strategy to prevent progression of asymptomatic plasma cell disorders, maintain disease control, and ultimately contribute to eradication of multiple myeloma, light and heavy chain amyloidosis, immunoglobulin deposition disease, and other malignant and non-malignant diseases related to transformed plasma cells. Primary Objective Confirm the safety of dendritic cell DKK1 vaccine given every two weeks for three doses in patients with monoclonal gammopathy, stable or smoldering myeloma. Secondary Objectives 1. Assess response according to international response criteria (\> partial response, PR) and clinical benefit response (\>minor response, MR, according to adapted EBMT criteria) 2. Determine time to progression 3. Describe progression-free and overall survival Correlative Objectives 1. Explore correlation between myeloma DKK1 and PDL-1 expression and response 2. Determine cellular immune response 3. Assess serologic anti-DKK1 antibody response Study design including dose escalation / cohorts Pilot study with 3 patient safety run-in, possible dose level -1 (DL-1) if dose limiting toxicity occurs in one or more patients at the target dose level, and, at the first dose level where no dose limiting toxicity occurs, extension by 12 patients. DLT will be defined as any vaccine related toxicity \> grade 3 that does not resolve to grade \< 2 within 7 days. If any DLT occurs at DL-1 enrollment will be stopped and an amendment will be discussed.

Conditions

• Monoclonal Gammopathy
• Smoldering Myeloma
• Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	DKK1	The investigational agent is a DKK1 peptide-loaded autologous dendritic cell vaccine dispensed at a dose of 5-10x106 in 0.5 mL Plasma-Lyte A + 5% HSA.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2018-07-19
• Last updated: 2023-08-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study