IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (NCT06677710) | Clinical Trial Compass
SuspendedPhase 1
IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
Stopped: Business Reasons
United States34 participantsStarted 2026-06-30
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Incidence of AEs and SAEs - (Part 1)
Timeframe: 1 year
2
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)
Timeframe: up to 21 days
3
Change in cellular response of autoreactive immune cells to antigen (Part 2)