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

April 28, 2025 updated by: Indapta Therapeutics, INC.

A Phase 1B Study of IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Refractory Primary and Secondary Progressive Multiple Sclerosis

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 the nervous system in multiple sclerosis (MS). By killing these harmful cells, g-NK cells may help to slow down or potentially stop the progression of MS. When combined with other approved treatments like ocrelizumab, g-NK cells might offer even greater benefit for people with MS.

This is an open label, Phase 1b, multiple ascending dose, and dose-expansion study of IDP- 023 administered in combination with IL-2 and ocrelizumab to evaluate the safety, tolerability, and biologic activity on autoreactive immune cells in patients with primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS).

The study is divided into Part 1, a dose escalation phase, and Part 2, an expansion phase.

Part 1 (Escalation Period): 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 (recommended Part 2 dose; RP2D).

Part 2 (Expansion Period): The objective of the Part 2 expansion phase is to assess the biologic activity of IDP-023 in combination with IL-2 and ocrelizumab on autoreactive immune cells in PPMS.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando - Adventist Health System/Sunbelt, Inc.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab
MS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Drug: Interleukin-2
Immune cytokine
Other Names:
  • Proleukin
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Drug: Ocrelizumab
Anti-CD20 antibody therapy
Other Names:
  • Ocrevus
Experimental: Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab
MS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Drug: Interleukin-2
Immune cytokine
Other Names:
  • Proleukin
Drug: Cyclophosphamide
Lymphodepleting chemotherapy
Drug: Fludarabine
Lymphodepleting chemotherapy
Drug: IDP-023
NK cell therapy
Drug: Mesna
Chemoprotectant
Drug: Ocrelizumab
Anti-CD20 antibody therapy
Other Names:
  • Ocrevus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of AEs and SAEs - (Part 1)
Time Frame: 1 year
Escalation Period
1 year
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)
Time Frame: up to 21 days
Escalation Period
up to 21 days
Change in cellular response of autoreactive immune cells to antigen (Part 2)
Time Frame: 2 years
Expansion Period
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cellular response of autoreactive immune cells to antigen (Part 1)
Time Frame: 2 year
Escalation Period
2 year
Incidence of AEs and SAEs - (Part 2)
Time Frame: 2 years
Expansion Period
2 years
PK (PK; maximum drug concentration) of IDP-023 - (Part 1/2)
Time Frame: 2 years
Escalation and Expansion periods
2 years
PK (area under the concentration-time curve) of IDP-023 - (Part 1/2)
Time Frame: 2 years
Escalation and Expansion periods
2 years
PK (concentration reached by the drug immediately before the next dose is administered) of IDP-023 - (Part 1/2)
Time Frame: 2 years
Escalation and Expansion periods
2 years
Time to onset of sustained disability progression over the treatment period, defined as an increase in Expanded Disability Status Scale (EDSS) - (Part 1/2)
Time Frame: 2 years
Escalation and Expansion periods
2 years
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)
Time Frame: 2 years
Escalation and Expansion periods
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indapta Therapeutics, INC.

Investigators

  • Study Director: Indapta Therapeutics, Inc., Indapta Therapeutics, INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDP023-2-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe