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CAR T-cell Therapy

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

Phase 1
Waitlist Available
Research Sponsored by Indapta Therapeutics, INC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Permanent Neurological Damage
  • Osmotic Demyelination Syndrome
  • Autoimmune Disease
  • Multiple Sclerosis
  • Autoimmune Neurological Diseases
  • Immune Disorders
  • Autoimmune Neuropathies
  • Nervous System Disorders
  • Autoimmune Diseases
  • Demyelination
  • Immune System Disorders
  • Multiple sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cellular response of autoreactive immune cells to antigen (Part 2)
Incidence of AEs and SAEs - (Part 1)
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)
Secondary study objectives
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)
Change in cellular response of autoreactive immune cells to antigen (Part 1)
Incidence of AEs and SAEs - (Part 2)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumabExperimental Treatment6 Interventions
MS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab
Group II: Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumabExperimental Treatment6 Interventions
MS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesna
2003
Completed Phase 2
~1380
Cyclophosphamide
2010
Completed Phase 4
~2310
Ocrelizumab
2016
Completed Phase 4
~8600
Interleukin-2
1994
Completed Phase 3
~690
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Indapta Therapeutics, INC.Lead Sponsor
1 Previous Clinical Trials
128 Total Patients Enrolled
Indapta Therapeutics, Inc.Study DirectorIndapta Therapeutics, INC.
1 Previous Clinical Trials
128 Total Patients Enrolled
~23 spots leftby Dec 2026
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