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

NCT06677710 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-04-30

No results posted yet for this study

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)

Interventions

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

Sponsors & Collaborators

  • Indapta Therapeutics, INC.

    lead INDUSTRY

Principal Investigators

  • Indapta Therapeutics, Inc. · Indapta Therapeutics, INC.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06677710 on ClinicalTrials.gov