IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis

Treatment tested

• IDP-023
• Ocrelizumab

  B-lymphocyte antigen CD20 binding agent

• Aldesleukin

  Interleukin-2 receptor agonist

• Cyclophosphamide anhydrous
• Fludarabine
• 2-mercaptoethanesulfonic acid

Other measures (7)

Key Inclusion Criteria: * Confirmed diagnosis of primary or non-active secondary progressive MS (SPMS) based on the 2017 revisions of the McDonald criteria. * Dosed with ocrelizumab within the prior 6 months. * Expanded Disability Status Scale (EDSS) at screening from 3.0 to 6.5 points. * Score of ≥2.0 on the Functional Systems (FS) scale for the pyramidal system that is due to lower extremity findings. * Disease duration from the onset of MS symptoms: * Less than 15 years in patients with an EDSS at screening >5.0. * Less than 10 years in patients with an EDSS at screening ≤5.0. Key Exclusion Criteria: * Relapsing remitting MS at screening or active SPMS at screening. * Inability to complete an MRI. * Contraindication for gadolinium. * Known presence of other neurological disorders, including but not limited to the following: * History or known presence of CNS or spinal cord tumor (e.g., meningioma, glioma). * History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, Human T-lymphotropic virus 1 [HTLV-1], herpes zoster myelopathy). * History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sjögren's syndrome, Behçet's disease). * Impaired cardiac function or history of clinical significant cardiac disease. * Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.

This is an open label, Phase 1b, 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 refractory progressive multiple sclerosis.