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CAR T-cell Therapy
IDP-023 + Ocrelizumab for Multiple Sclerosis
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
Score of ≥2.0 on the Functional Systems (FS) scale for the pyramidal system that is due to lower extremity findings
Must not have
Inability to complete an MRI
Relapsing remitting MS at screening or active SPMS at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new medication, IDP-023, in combination with interleukin-2 (IL-2) and ocrelizumab to see how safe and effective it
Who is the study for?
This trial is for patients with progressive multiple sclerosis who have not responded to standard treatments. Participants must be adults capable of giving consent and should not have other autoimmune diseases, oral cancers, or conditions that could interfere with the study.
What is being tested?
The trial tests a combination treatment using IDP-023 g-NK cells with Ocrelizumab and other drugs like Mesna, Cyclophosphamide, Interleukin-2, and Fludarabine. It's an early-phase study to check safety and effects on immune cells in MS patients.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, allergic responses, fatigue, nausea, and potential worsening of neurological symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MS is diagnosed as primary or secondary progressive.
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I have mobility issues in my legs.
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My MS symptoms started less than 15 years ago and my disability is significant.
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I have been treated with ocrelizumab in the last 6 months.
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My disability level is moderate to severe but I can still walk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot undergo an MRI scan.
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My MS is currently in a relapsing-remitting phase or is actively worsening.
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I have HIV, active hepatitis B, or hepatitis C.
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I have heart problems or a history of significant heart disease.
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I do not have any other neurological disorders or conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
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 moreAwards & 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
Interleukin-2
1994
Completed Phase 3
~840
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2310
Mesna
2003
Completed Phase 2
~1380
Ocrelizumab
2016
Completed Phase 4
~10080
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