NCT06677710

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

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

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Indapta Therapeutics, INC. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

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)

Interventions

Type	Name	Description
DRUG	IDP-023	NK cell therapy
DRUG	Ocrelizumab	Anti-CD20 antibody therapy
DRUG	Interleukin-2	Immune cytokine
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy
DRUG	Mesna	Chemoprotectant

Timeline

• Start date: 2026-06-30
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-11-07
• Last updated: 2025-04-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study