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

Registration Number
NCT06677710
Lead Sponsor
Indapta Therapeutics, INC.
Brief 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.

Detailed Description

IDP-023 is an off-the-shelf product made from allogeneic g-natural killer (NK) cells, which are a natural subset of NK cells that develop over the course of an immune response in people who have been exposed to the human cytomegalovirus (HCMV). These cells may be particularly effective at targeting and killing the cells that cause the immune system to attack...

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
34
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

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabCyclophosphamideMS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabOcrelizumabMS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabInterleukin-2MS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabMesnaMS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabIDP-023MS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabInterleukin-2MS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabCyclophosphamideMS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabFludarabineMS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabFludarabineMS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabMesnaMS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabIDP-023MS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabOcrelizumabMS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Primary Outcome Measures
NameTimeMethod
Incidence of AEs and SAEs - (Part 1)1 year

Escalation Period

Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)up to 21 days

Escalation Period

Change in cellular response of autoreactive immune cells to antigen (Part 2)2 years

Expansion Period

Secondary Outcome Measures
NameTimeMethod
Change in cellular response of autoreactive immune cells to antigen (Part 1)2 year

Escalation Period

Incidence of AEs and SAEs - (Part 2)2 years

Expansion Period

PK (PK; maximum drug concentration) of IDP-023 - (Part 1/2)2 years

Escalation and Expansion periods

PK (area under the concentration-time curve) of IDP-023 - (Part 1/2)2 years

Escalation and Expansion periods

PK (concentration reached by the drug immediately before the next dose is administered) of IDP-023 - (Part 1/2)2 years

Escalation and Expansion periods

Time to onset of sustained disability progression over the treatment period, defined as an increase in Expanded Disability Status Scale (EDSS) - (Part 1/2)2 years

Escalation and Expansion periods

Biologic activity of IDP-023 in the CSF over the treatment period - (Part 1/2) over the treatment period, defined as an increase in EDSS - (Part 1/2)2 years

Escalation and Expansion periods

Trial Locations

Locations (4)

University of California San Francisco

🇺🇸

San Francisco, California, United States

AdventHealth Orlando - Adventist Health System/Sunbelt, Inc.

🇺🇸

Orlando, Florida, United States

Stanford University

🇺🇸

Stanford, California, United States

Washington University in St. Louis

🇺🇸

Saint Louis, Missouri, United States

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