Multiple SclerosisPhase 1NCT06677710
IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
A Phase 1 study testing IDP-023, Ocrelizumab and Interleukin-2 in people with Multiple Sclerosis and Primary Progressive Multiple Sclerosis (PPMS), run by Indapta Therapeutics, INC. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS)
- What is being tested?
- IDP-023, Ocrelizumab and Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Kansas University Medical Center
Kansas City, Kansas, 66160
AdventHealth Orlando - Adventist Health System/Sunbelt, Inc.
Orlando, Florida, 32803
Washington University in St. Louis
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase 1B Study of IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Refractory Primary and Secondary Progressive Multiple Sclerosis
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.
Read the 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
- Being tested
- IDP-023, Ocrelizumab, Interleukin-2, Cyclophosphamide, Fludarabine
- Keywords
- Progressive Multiple Sclerosis, Refractory Progressive Multiple Sclerosis, IDP-023, autoimmune disease, Cellular Therapy, MS, Natural Killer Cells
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-023Drug
NK cell therapy
OcrelizumabDrug
Also called Ocrevus
Anti-CD20 antibody therapy
Interleukin-2Drug
Also called Proleukin
Immune cytokine
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
MesnaDrug
Chemoprotectant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: IDP-023; Drug: Ocrelizumab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs - (Part 1)
Escalation Period
Measured: 1 year
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)
Escalation Period
Measured: up to 21 days
Change in cellular response of autoreactive immune cells to antigen (Part 2)
Expansion Period
Measured: 2 years
Secondary outcomes (7)
Change in cellular response of autoreactive immune cells to antigen (Part 1)
Escalation Period
Measured: 2 year
Incidence of AEs and SAEs - (Part 2)
Expansion Period
Measured: 2 years
PK (PK; maximum drug concentration) of IDP-023 - (Part 1/2)
Escalation and Expansion periods
Measured: 2 years
PK (area under the concentration-time curve) of IDP-023 - (Part 1/2)
Escalation and Expansion periods
Measured: 2 years
PK (concentration reached by the drug immediately before the next dose is administered) of IDP-023 - (Part 1/2)
Escalation and Expansion periods
Measured: 2 years
Time to onset of sustained disability progression over the treatment period, defined as an increase in Expanded Disability Status Scale (EDSS) - (Part 1/2)
Escalation and Expansion periods
Measured: 2 years
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)
Escalation and Expansion periods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multiple ascending dose and dose-expansion study of IDP-023 in combination with interleukin-2 (IL-2) and ocrelizumab.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indapta Therapeutics, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Indapta Therapeutics, Inc., Study director, Indapta Therapeutics, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677710
- Sponsor's protocol ID
- IDP023-2-101
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Study of IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Refractory Primary and Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06677710
- Acronym / sponsor ID
- IDP023-2-101
- 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
- Keywords
- Progressive Multiple Sclerosis, Refractory Progressive Multiple Sclerosis, IDP-023, autoimmune disease, Cellular Therapy, MS, Natural Killer Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Business Reasons
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Indapta Therapeutics, INC.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple ascending dose and dose-expansion study of IDP-023 in combination with interleukin-2 (IL-2) and ocrelizumab.
| Arm | Type | Receives |
|---|---|---|
| Part 1 (dose escalation): IDP-023 in combination with IL-2 and ocrelizumab | Experimental | Drug: IDP-023, Drug: Ocrelizumab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaMS patients treated with multiple doses of IDP-023 in combination with IL-2 and ocrelizumab |
| Part 2 (dose expansion): IDP-023 in combination with IL-2 and ocrelizumab | Experimental | Drug: IDP-023, Drug: Ocrelizumab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaMS patients treated with the recommended dose of IDP-023 in combination with IL-2 and ocrelizumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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:
- Impaired cardiac function or history of clinical significant cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDP-023NK cell therapy | Drug | 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 |
| OcrelizumabAlso: OcrevusAnti-CD20 antibody therapy | Drug | 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-2Also: ProleukinImmune cytokine | Drug | 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 |
| CyclophosphamideLymphodepleting chemotherapy | Drug | 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 |
| FludarabineLymphodepleting chemotherapy | Drug | 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 |
| MesnaChemoprotectant | Drug | 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 |
Primary outcome
Incidence of AEs and SAEs - (Part 1)
Time frame: 1 year
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with IL-2 and Ocrelizumab (Part 1)
Time frame: up to 21 days
Escalation Period
Change in cellular response of autoreactive immune cells to antigen (Part 2)
Time frame: 2 years
Expansion Period
7 secondary outcomes
Change in cellular response of autoreactive immune cells to antigen (Part 1)
Time frame: 2 year
Incidence of AEs and SAEs - (Part 2)
Time frame: 2 years
PK (PK; maximum drug concentration) of IDP-023 - (Part 1/2)
Time frame: 2 years
PK (area under the concentration-time curve) of IDP-023 - (Part 1/2)
Time frame: 2 years
PK (concentration reached by the drug immediately before the next dose is administered) of IDP-023 - (Part 1/2)
Time frame: 2 years
Time to onset of sustained disability progression over the treatment period, defined as an increase in Expanded Disability Status Scale (EDSS) - (Part 1/2)
Time frame: 2 years
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)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indapta Therapeutics, Inc. study director
Indapta Therapeutics, INC.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDP-023, Ocrelizumab and Interleukin-2 in people with Multiple Sclerosis and Primary Progressive Multiple Sclerosis (PPMS), run by Indapta Therapeutics, INC. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs and SAEs - (Part 1) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.