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

NCT06677710 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: IDP023-2-101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Sclerosis; Primary Progressive Multiple Sclerosis (PPMS); Secondary Progressive Multiple Sclerosis (SPMS); Non-Active Secondary Progressive Multiple Sclerosis; Non-Active SPMS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Demyelinating Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, Central Nervous System (CNS)

Keywords

Progressive Multiple Sclerosis; Refractory Progressive Multiple Sclerosis; IDP-023; autoimmune disease; Cellular Therapy; MS; Natural Killer Cells

Outcome Measures

Primary Outcomes (3)

• Incidence of AEs and SAEs - (Part 1)

  Escalation Period

  1 year

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

  Escalation Period

  up to 21 days

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

  Expansion Period

  2 years

Secondary Outcomes (7)

• Change in cellular response of autoreactive immune cells to antigen (Part 1)

  2 year

• Incidence of AEs and SAEs - (Part 2)

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (2)

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab

EXPERIMENTAL

MS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab

Drug: IDP-023; Drug: Ocrelizumab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

EXPERIMENTAL

MS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab

Drug: IDP-023; Drug: Ocrelizumab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna

Interventions

IDP-023 DRUG

NK cell therapy

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Ocrelizumab DRUG

Anti-CD20 antibody therapy

Also known as: Ocrevus

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Interleukin-2 DRUG

Immune cytokine

Also known as: Proleukin

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Fludarabine DRUG

Lymphodepleting chemotherapy

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Mesna DRUG

Chemoprotectant

Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab; Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indapta Therapeutics, INC.: lead

Study Sites (5)

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

AdventHealth Orlando - Adventist Health System/Sunbelt, Inc.

Orlando, Florida, 32803, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Demyelinating Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS

Interventions

ocrelizumab; Interleukin-2; aldesleukin; Cyclophosphamide; fludarabine; Mesna

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Indapta Therapeutics, Inc.

  Indapta Therapeutics, INC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple ascending dose and dose-expansion study of IDP-023 in combination with interleukin-2 (IL-2) and ocrelizumab.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)