Under the leadership of neurologist and Medical Director of Neuroscience Research Anita Fletcher, MD, the AdventHealth Neuroscience Institute is recruiting patients for IDP023-2-101, a new Phase Ib clinical trial of investigational drug IDP-023 for people with primary progressive or non-active secondary progressive multiple sclerosis (MS).
Administered intravenously, IDP-023 is made up of a rare subset of natural killer (NK) cells called g-NK cells that lack a specific protein called FcεR1γ. They arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). These g-NK cells are thought to play a role in reducing the progression of MS by targeting and killing the harmful human leukocyte antigen E (HLA-E) expressing autoreactive T and B cells that are causing the immune system to attack the nervous system. Compared with conventional NK cells, g-NK cells release more immune activating cytokines and cell-killing compounds.
The IDP023-2-101 trial is a multicenter, global study designed to evaluate the safety and tolerability of IDP-023 when given in combination with ocrelizumab, a disease modifying monoclonal antibody therapy approved by the FDA to treat forms of progressing MS in adults. The trial will test 3 different dose levels of IDP-023. There is no placebo group so all qualified participants will receive the active study treatment.
Challenges in Treating Progressive Multiple Sclerosis
An estimated 2.9 million people live with MS worldwide, including nearly 1 million in the U.S. Primary progressive multiple sclerosis (PPMS) is a type of MS in which symptoms get worse over time, rather than the more common pattern of relapsing multiple sclerosis (RMS). PPMS represents about 10% to 15% of all MS cases, and people with it usually experience slowly worsening symptoms, with less frequent sudden relapses.
Additionally, many people who have RMS later develop another type of MS called secondary progressive multiple sclerosis (SPMS). Persons with SPMS experience worsening of neurological deficits associated with increase of disability. Treatment options for PPMS or non-active SPMS are limited. Currently ocrelizumab is the only FDA-approved medication for PPMS.
“There have been significant advancements in treating relapsing multiple sclerosis. However, most of the standard-of-care disease-modifying therapies available to us are not fully effective in slowing progression for PPMS or non-active SPMS,” explains Dr. Fletcher. “This is because the disease-modifying medications we currently have aim to reduce inflammation in the central nervous system, and with the progressive forms of multiple sclerosis, the primary challenge is nerve degeneration rather than inflammation. The aim of IDP023 is to realign the patient’s immune system to slow or halt progression of the MS.”
About the IDP023-2-101 Study
The AdventHealth Neuroscience Institute is seeking people ages 18 to 65 who have been treated with ocrelizumab in the past 6 months for PPMS or SPMS to participate in IDP023-2-101. It is a multiple ascending dose and dose-expansion study of IDP-023 administered in combination with interleukin-2 (IL-2) and ocrelizumab to evaluate the safety, tolerability and biologic activity on autoreactive immune cells in patients with PPMS or SPMS.
The study is divided into two parts. Part 1 is a dose escalation phase, and Part 2 is a dose expansion phase. The primary objectives of Part 1 are to define the safety of different dose levels of IDP-023 in combination with IL-2 and ocrelizumab, and to define the recommended cell dose that will be used for Part 2. The primary objective of Part 2 is to assess the biologic activity of IDP-023 in combination with IL-2 and ocrelizumab on autoreactive immune cells in PPMS.
Eligible study participants will receive treatment with IDP-023 for up to 5 days and may be hospitalized for at least 4 days. They will return to the clinic for evaluation within 1 week or 30 days and then approximately every 3 months for the next 2 years. MRI scan assessments, symptom assessments, cerebrospinal fluid collections, lymph node biopsies, and tests from blood samples will be used to evaluate the effects of the treatment.
“We’re excited to be the only site in Florida and one of the first in the country to offer this groundbreaking clinical trial,” shares Dr. Fletcher. “Studies like these are a key part of our commitment to finding new and better treatments that could improve the quality of life for patients suffering from MS.”
To learn more, visit https://www.adventhealth.com/institute/adventhealth-research-institute/neuroscience-research.
