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

SuspendedPhase 1

Sponsor: Indapta Therapeutics, INC.

Conditions: Multiple Sclerosis, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), Non-Active Secondary Progressive Multiple Sclerosis, Non-Active SPMS

Interventions: IDP-023, Ocrelizumab, Interleukin-2, Cyclophosphamide, Fludarabine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (5)

Stanford, California, United States
Aurora, Colorado, United States
Orlando, Florida, United States
Kansas City, Kansas, United States
St Louis, Missouri, United States