Rheumatoid ArthritisPhase 1/2MACRA-FIH-1NCT07349420
EF-M2 (Immutalon) Multiple Ascending Dose Study in Moderate-to-Severe Rheumatoid Arthritis
A Phase 1/2 study testing EF-M2 in people with Rheumatoid Arthritis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This is a first-in-human, open-label, phase I/IIa, multiple ascending dose study of EF-M2 (Immutalon), a macrophage-modulating investigational product intended to shift macrophages toward an anti-inflammatory (M2-like) phenotype via a CLEC10A-mediated mechanism. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- EF-M2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jun 2025to 6 Dec 2025
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years.
- Diagnosis of rheumatoid arthritis according to the 2010 American College of - Rheumatology and European Alliance of Associations for Rheumatology classification criteria for at least 6 months.
- Moderate-to-severe active disease, defined as:
- Disease Activity Score in 28 joints using C-reactive protein at least 3.2 and not more than 6.0; and
- At least 6 tender joints and at least 6 swollen joints based on the 28-joint count.
- Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (for example, methotrexate or leflunomide); and either:
Show all 13Show fewer
- No prior biologic or targeted synthetic disease-modifying antirheumatic drug therapy; or
- No more than one prior line of biologic or targeted synthetic disease-modifying antirheumatic drug therapy, discontinued at least 12 weeks before screening.
- Stable background therapy:
- Conventional synthetic disease-modifying antirheumatic drug at a stable dose for at least 8 weeks; and
- Glucocorticoids at a dose not exceeding 10 milligrams per day of prednisone (or equivalent) at a stable dose for at least 4 weeks; and
- Nonsteroidal anti-inflammatory drugs and/or analgesics on a stable regimen for at least 2 weeks.
- Willingness and ability to comply with study visits, biospecimen collection, and contraception requirements (for women and men).
Who cannot join
- Current severe infection; active or latent tuberculosis without completed preventive therapy.
- Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus infection with high viral load.
- Active malignancy or history of malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or skin.
- History of severe opportunistic infections.
- Uncontrolled cardiovascular disease (including New York Heart Association class III or IV heart failure, acute coronary syndrome within the past 6 months, or uncontrolled arterial hypertension), decompensated diabetes mellitus, or severe liver or kidney disease.
- Pregnancy, breastfeeding, or planning pregnancy within 6 months.
- Prior treatment with cellular therapies, chimeric antigen receptor T-cell therapy, or profound immunosuppressive therapies with incomplete immune reconstitution.
- Any condition that, in the investigator's opinion, increases the risk of study participation.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center for New Medical Technologies
Novosibirsk, Novosibirsk Oblast, 630090
About this study
Official title: CLEC10A-Targeted M2 Macrophage Repolarization With EF-M2 (Immutalon) in Patients With Moderate-to-Severe Rheumatoid Arthritis: An Open-Label, Multicenter, First-in-Human Phase I/IIa Multiple Ascending Dose Study
This is a first-in-human, open-label, phase I/IIa, multiple ascending dose study of EF-M2 (Immutalon), a macrophage-modulating investigational product intended to shift macrophages toward an anti-inflammatory (M2-like) phenotype via a CLEC10A-mediated mechanism. The study will enroll adults with moderate-to-severe rheumatoid arthritis.
Participants will receive EF-M2 as subcutaneous injections for 4 weeks in sequential dose cohorts (1, 3, 5, or 7 mcg administered twice weekly; optional expanded pharmacodynamic cohorts may receive 3 or 5 mcg three times weekly). The total number of injections will be 8-12 depending on the regimen. Dose escalation is sequential and overseen by an independent data safety monitoring board (DSMB), with sentinel dosing at the start of each new cohort. Participants may be followed off drug for up to 8-12 weeks after treatment, for a total participation time of up to 16 weeks (including screening).
The primary objective is to evaluate safety, tolerability, and immunogenicity. Secondary objectives include assessing pharmacodynamic markers of M2 polarization (e.g., changes in ARG1/iNOS and IL-10/TNF-α ratios and M2-associated cell phenotypes) and exploring associations with clinical activity measures.
Read the detailed description
This phase I/IIa, open-label, multicenter, multiple ascending dose (MAD) study evaluates EF-M2 (Immutalon) administered subcutaneously to adults with moderate-to-severe rheumatoid arthritis. The trial is designed primarily to characterize safety/tolerability and immunogenicity and to describe pharmacodynamic (PD) evidence of macrophage M2 polarization rather than to demonstrate definitive clinical efficacy.
Participants are enrolled into sequential dose cohorts. Each participant receives EF-M2 for 4 weeks: Cohorts 1-4 receive 1, 3, 5, or 7 mcg twice weekly (8 injections total). If needed, expanded PD cohorts may evaluate 3 mcg or 5 mcg administered three times weekly (12 injections total) to better understand whether increased dosing frequency strengthens the M2 PD signature and where a plateau may begin. Dose escalation is sequential and occurs only after DSMB review of safety and PD data; sentinel dosing is used in each new cohort (the first 2 participants receive initial dosing with an observation period before full cohort enrollment continues).
Key assessments include adverse event monitoring, physical examinations and vital signs at visits, laboratory safety testing at scheduled time points, and immunogenicity testing (anti-drug antibodies, with neutralizing antibodies assessed if antibodies are detected). Pharmacodynamic assessments are based on blood markers measured over time (e.g., soluble cytokines and macrophage/monocyte markers), with PD endpoints including change in ARG1/iNOS and IL-10/TNF-α ratios and changes in M2-associated cell phenotypes.
Study timing includes screening up to 28 days, 4 weeks of treatment, and an off-drug follow-up period of 8-12 weeks (total participation up to 16 weeks). Example follow-up assessments extend through Day 112. The planned sample size is approximately 32 participants (8 per cohort across four dose levels), with up to 48 participants if both expanded PD cohorts are activated.
- Conditions
- Rheumatoid Arthritis
- Being tested
- EF-M2
- Keywords
- EF-M2, Immutalon, Multiple Ascending Dose, Macrophage Repolarization
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF-M2Drug
EF-M2 (Immutalon) is an investigational product administered as a subcutaneous injection. In this study, participants receive EF-M2 for 4 weeks in sequential multiple ascending dose cohorts: 1, 3, 5, or 7 mcg twice weekly (8 injections total). Optional expanded pharmacodynamic cohorts may receive 3 or 5 mcg three times weekly (12 injections total).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: EF-M2 1 mcg SC Twice Weekly | Experimental | Participants receive EF-M2 (Immutalon) 1 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). Receives: Drug: EF-M2 |
| Cohort 2: EF-M2 3 mcg SC Twice Weekly | Experimental | Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). Receives: Drug: EF-M2 |
| Cohort 4: EF-M2 7 mcg SC Twice Weekly | Experimental | Participants receive EF-M2 (Immutalon) 7 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). Receives: Drug: EF-M2 |
| Cohort 5: EF-M2 3 mcg SC Three Times Weekly | Experimental | Participants receive EF-M2 (Immutalon) 3 mcg by subcutaneous injection three times weekly for 4 weeks (12 injections total). Optional expanded pharmacodynamic cohort. Receives: Drug: EF-M2 |
| Cohort 6: EF-M2 5 mcg SC Three Times Weekly | Experimental | Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection three times weekly for 4 weeks (12 injections total). Optional expanded pharmacodynamic cohort. Receives: Drug: EF-M2 |
| Cohort 3: EF-M2 5 mcg SC Twice Weekly | Experimental | Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). Receives: Drug: EF-M2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Number and percentage of participants with any treatment-emergent adverse event and with any serious adverse event during the study. Events will be coded and summarized by severity and relationship to study drug; severity will be graded using the Common Terminology Criteria for Adverse Events.
Range and Units: Count: 0 to total number of participants. Percentage: 0% to 100%.
Measured: From first dose (Day 0) through end of follow-up (Day 112)
Incidence of Dose-Limiting Toxicities
Number and percentage of participants who experience a dose-limiting toxicity during the dose-limiting toxicity evaluation period (pre-defined clinically significant toxicities, including severe toxicities graded using the Common Terminology Criteria for Adverse Events, immune complications, and severe infections as specified by protocol).
Range and Units: Count: 0 to total number of participants in the cohort. Percentage: 0% to 100%.
Measured: From first dose (Day 0) through end of dosing period (Day 28)
Percentage of Participants With Treatment-Emergent Clinically Significant Laboratory Abnormalitie
Treatment-emergent clinically significant laboratory abnormality is defined as a post-baseline abnormality meeting Grade 3 or Grade 4 severity criteria (per CTCAE v5.0, or equivalent protocol-defined grading) in any of the assessed laboratory parameters, including hematology (CBC with differential and platelets), serum chemistry (ALT, AST, alkaline phosphatase, bilirubin, creatinine, urea, electrolytes), inflammatory markers (C-reactive protein, fibrinogen), and immune markers (immunoglobulins and complement).
A participant will be counted once if they experience ≥1 qualifying abnormality at any post-baseline assessment. Results will be summarized as a percentage of participants.
Measured: Baseline (Day 0) and Days 7, 14, 28, 56, 84, and 112
Proportion of Participants With Anti-Drug Antibodies and Neutralizing Antibodies to EF-M2
Number and percentage of participants with a positive anti-drug antibody result to EF-M2 in serum. Neutralizing antibodies will be assessed in participants with positive anti-drug antibodies.
Range and Units: Count: 0 to total number of participants tested. Percentage: 0% to 100%.
Measured: Baseline (Day 0) and Days 28, 56, 84, and 112
Secondary outcomes (5)
Change From Baseline in Arginase 1 to Inducible Nitric Oxide Synthase Ratio
Change from baseline in the ratio of arginase 1 to inducible nitric oxide synthase measured in enriched peripheral blood monocytes using reverse transcription quantitative polymerase chain reaction. The outcome is expressed as a unitless ratio.
Range and Units: Unitless ratio; minimum 0; no protocol-defined maximum. Change from baseline can be negative or positive.
Measured: Baseline (Day 0) to Day 28, Day 56, and Day 84
Change From Baseline in Plasma Interleukin 10 to Tumor Necrosis Factor Alpha Ratio
Change from baseline in the ratio of plasma interleukin 10 concentration to plasma tumor necrosis factor alpha concentration, measured using multiplex cytokine panels. The outcome is expressed as a unitless ratio.
Range and Units: Unitless ratio; minimum 0; no protocol-defined maximum. Change from baseline can be negative or positive.
Measured: (Day 0) to Day 28, Day 56, and Day 84
Change From Baseline in Proportion of Monocytes With M2-Associated Phenotype
hange from baseline in the proportion of peripheral blood monocytes/macrophage-lineage cells with an M2-associated phenotype, defined by expression of mannose receptor C-type 1 (also known as cluster of differentiation 206) and MER proto-oncogene, tyrosine kinase (also known as MerTK), assessed by flow cytometry or mass cytometry within the monocyte population (cluster of differentiation 14 positive, cluster of differentiation 16 plus/minus).
Range and Units: Percentage: 0% to 100%. Change from baseline can be negative or positive (percentage points).
Measured: Baseline (Day 0) to Day 28, Day 56, and Day 84
Pharmacodynamic Differences Between Dose Levels and Dosing Regimens
Differences between dose levels (1, 3, 5, and 7 micrograms) and dosing regimens (twice weekly versus three times weekly, if expanded cohorts are activated) in change from baseline pharmacodynamic markers of M2 polarization, including (1) arginase 1 to inducible nitric oxide synthase ratio and (2) plasma interleukin 10 to tumor necrosis factor alpha ratio.
Range and Units: Between-group difference in change from baseline for unitless ratios; no protocol-defined minimum or maximum.
Measured: Baseline (Day 0) to Day 28, Day 56, and Day 84
Dose-Pharmacodynamic Relationship for M2 Polarization Markers
Dose-pharmacodynamic relationship for change from baseline in (1) arginase 1 to inducible nitric oxide synthase ratio and (2) plasma interleukin 10 to tumor necrosis factor alpha ratio, evaluated across dose levels (and dosing frequency if applicable) using nonlinear dose-response modeling (for example, maximum effect models).
Range and Units: Model-based relationship for unitless ratios; no protocol-defined minimum or maximum.
Measured: Baseline (Day 0) to Day 28, Day 56, and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start3 Jun 2025
- Primary completion5 Oct 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, multiple ascending dose study with sequential cohort dose escalation. Participants receive EF-M2 (Immutalon) by subcutaneous injection for 4 weeks (twice weekly in Cohorts 1-4). Optional expanded pharmacodynamic cohorts may evaluate increased dosing frequency (three times weekly). Sentinel dosing is used at the start of each new cohort, and dose escalation proceeds after DSMB review of safety and pharmacodynamic data.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Activator MAF, LLC, Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349420
- Sponsor's protocol ID
- SW032
- Acronym
- MACRA-FIH-1
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEC10A-Targeted M2 Macrophage Repolarization With EF-M2 (Immutalon) in Patients With Moderate-to-Severe Rheumatoid Arthritis: An Open-Label, Multicenter, First-in-Human Phase I/IIa Multiple Ascending Dose Study
- ClinicalTrials.gov ID
- NCT07349420
- Acronym / sponsor ID
- MACRA-FIH-1 / SW032
- Conditions
- Rheumatoid Arthritis
- Keywords
- EF-M2, Immutalon, Multiple Ascending Dose, Macrophage Repolarization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Activator MAF, LLC, Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 5 Oct 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 16 Jan 2026 (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 a first-in-human, open-label, phase I/IIa, multiple ascending dose study of EF-M2 (Immutalon), a macrophage-modulating investigational product intended to shift macrophages toward an anti-inflammatory (M2-like) phenotype via a CLEC10A-mediated mechanism. The study will enroll adults with moderate-to-severe rheumatoid arthritis.
Participants will receive EF-M2 as subcutaneous injections for 4 weeks in sequential dose cohorts (1, 3, 5, or 7 mcg administered twice weekly; optional expanded pharmacodynamic cohorts may receive 3 or 5 mcg three times weekly). The total number of injections will be 8-12 depending on the regimen. Dose escalation is sequential and overseen by an independent data safety monitoring board (DSMB), with sentinel dosing at the start of each new cohort. Participants may be followed off drug for up to 8-12 weeks after treatment, for a total participation time of up to 16 weeks (including screening).
The primary objective is to evaluate safety, tolerability, and immunogenicity. Secondary objectives include assessing pharmacodynamic markers of M2 polarization (e.g., changes in ARG1/iNOS and IL-10/TNF-α ratios and M2-associated cell phenotypes) and exploring associations with clinical activity measures.
Detailed description
This phase I/IIa, open-label, multicenter, multiple ascending dose (MAD) study evaluates EF-M2 (Immutalon) administered subcutaneously to adults with moderate-to-severe rheumatoid arthritis. The trial is designed primarily to characterize safety/tolerability and immunogenicity and to describe pharmacodynamic (PD) evidence of macrophage M2 polarization rather than to demonstrate definitive clinical efficacy.
Participants are enrolled into sequential dose cohorts. Each participant receives EF-M2 for 4 weeks: Cohorts 1-4 receive 1, 3, 5, or 7 mcg twice weekly (8 injections total). If needed, expanded PD cohorts may evaluate 3 mcg or 5 mcg administered three times weekly (12 injections total) to better understand whether increased dosing frequency strengthens the M2 PD signature and where a plateau may begin. Dose escalation is sequential and occurs only after DSMB review of safety and PD data; sentinel dosing is used in each new cohort (the first 2 participants receive initial dosing with an observation period before full cohort enrollment continues).
Key assessments include adverse event monitoring, physical examinations and vital signs at visits, laboratory safety testing at scheduled time points, and immunogenicity testing (anti-drug antibodies, with neutralizing antibodies assessed if antibodies are detected). Pharmacodynamic assessments are based on blood markers measured over time (e.g., soluble cytokines and macrophage/monocyte markers), with PD endpoints including change in ARG1/iNOS and IL-10/TNF-α ratios and changes in M2-associated cell phenotypes.
Study timing includes screening up to 28 days, 4 weeks of treatment, and an off-drug follow-up period of 8-12 weeks (total participation up to 16 weeks). Example follow-up assessments extend through Day 112. The planned sample size is approximately 32 participants (8 per cohort across four dose levels), with up to 48 participants if both expanded PD cohorts are activated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Open-label, multiple ascending dose study with sequential cohort dose escalation. Participants receive EF-M2 (Immutalon) by subcutaneous injection for 4 weeks (twice weekly in Cohorts 1-4). Optional expanded pharmacodynamic cohorts may evaluate increased dosing frequency (three times weekly). Sentinel dosing is used at the start of each new cohort, and dose escalation proceeds after DSMB review of safety and pharmacodynamic data.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: EF-M2 1 mcg SC Twice Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 1 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). |
| Cohort 2: EF-M2 3 mcg SC Twice Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). |
| Cohort 4: EF-M2 7 mcg SC Twice Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 7 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). |
| Cohort 5: EF-M2 3 mcg SC Three Times Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 3 mcg by subcutaneous injection three times weekly for 4 weeks (12 injections total). Optional expanded pharmacodynamic cohort. |
| Cohort 6: EF-M2 5 mcg SC Three Times Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection three times weekly for 4 weeks (12 injections total). Optional expanded pharmacodynamic cohort. |
| Cohort 3: EF-M2 5 mcg SC Twice Weekly | Experimental | Drug: EF-M2Participants receive EF-M2 (Immutalon) 5 mcg by subcutaneous injection twice weekly for 4 weeks (8 injections total). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 70 years.
- Diagnosis of rheumatoid arthritis according to the 2010 American College of - Rheumatology and European Alliance of Associations for Rheumatology classification criteria for at least 6 months.
- Moderate-to-severe active disease, defined as:
- Disease Activity Score in 28 joints using C-reactive protein at least 3.2 and not more than 6.0; and
- At least 6 tender joints and at least 6 swollen joints based on the 28-joint count.
Key exclusion criteria (8 listed)
- Current severe infection; active or latent tuberculosis without completed preventive therapy.
- Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus infection with high viral load.
- Active malignancy or history of malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or skin.
- History of severe opportunistic infections.
- Uncontrolled cardiovascular disease (including New York Heart Association class III or IV heart failure, acute coronary syndrome within the past 6 months, or uncontrolled arterial hypertension), decompensated diabetes mellitus, or severe liver or kidney 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 |
|---|---|---|
| EF-M2EF-M2 (Immutalon) is an investigational product administered as a subcutaneous injection. In this study, participants receive EF-M2 for 4 weeks in sequential multiple ascending dose cohorts: 1, 3, 5, or 7 mcg twice weekly (8 injections total). Optional expanded pharmacodynamic cohorts may receive 3 or 5 mcg three times weekly (12 injections total). | Drug | Cohort 1: EF-M2 1 mcg SC Twice Weekly, Cohort 2: EF-M2 3 mcg SC Twice Weekly, Cohort 3: EF-M2 5 mcg SC Twice Weekly, Cohort 4: EF-M2 7 mcg SC Twice Weekly, Cohort 5: EF-M2 3 mcg SC Three Times Weekly, Cohort 6: EF-M2 5 mcg SC Three Times Weekly |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From first dose (Day 0) through end of follow-up (Day 112)
Number and percentage of participants with any treatment-emergent adverse event and with any serious adverse event during the study. Events will be coded and summarized by severity and relationship to study drug; severity will be graded using the Common Terminology Criteria for Adverse Events. Range and Units: Count: 0 to total number of participants. Percentage: 0% to 100%.
Incidence of Dose-Limiting Toxicities
Time frame: From first dose (Day 0) through end of dosing period (Day 28)
Number and percentage of participants who experience a dose-limiting toxicity during the dose-limiting toxicity evaluation period (pre-defined clinically significant toxicities, including severe toxicities graded using the Common Terminology Criteria for Adverse Events, immune complications, and severe infections as specified by protocol). Range and Units: Count: 0 to total number of participants in the cohort. Percentage: 0% to 100%.
Percentage of Participants With Treatment-Emergent Clinically Significant Laboratory Abnormalitie
Time frame: Baseline (Day 0) and Days 7, 14, 28, 56, 84, and 112
Treatment-emergent clinically significant laboratory abnormality is defined as a post-baseline abnormality meeting Grade 3 or Grade 4 severity criteria (per CTCAE v5.0, or equivalent protocol-defined grading) in any of the assessed laboratory parameters, including hematology (CBC with differential and platelets), serum chemistry (ALT, AST, alkaline phosphatase, bilirubin, creatinine, urea, electrolytes), inflammatory markers (C-reactive protein, fibrinogen), and immune markers (immunoglobulins and complement). A participant will be counted once if they experience ≥1 qualifying abnormality at any post-baseline assessment. Results will be summarized as a percentage of participants.
Proportion of Participants With Anti-Drug Antibodies and Neutralizing Antibodies to EF-M2
Time frame: Baseline (Day 0) and Days 28, 56, 84, and 112
Number and percentage of participants with a positive anti-drug antibody result to EF-M2 in serum. Neutralizing antibodies will be assessed in participants with positive anti-drug antibodies. Range and Units: Count: 0 to total number of participants tested. Percentage: 0% to 100%.
5 secondary outcomes
Change From Baseline in Arginase 1 to Inducible Nitric Oxide Synthase Ratio
Time frame: Baseline (Day 0) to Day 28, Day 56, and Day 84
Change From Baseline in Plasma Interleukin 10 to Tumor Necrosis Factor Alpha Ratio
Time frame: (Day 0) to Day 28, Day 56, and Day 84
Change From Baseline in Proportion of Monocytes With M2-Associated Phenotype
Time frame: Baseline (Day 0) to Day 28, Day 56, and Day 84
Pharmacodynamic Differences Between Dose Levels and Dosing Regimens
Time frame: Baseline (Day 0) to Day 28, Day 56, and Day 84
Dose-Pharmacodynamic Relationship for M2 Polarization Markers
Time frame: Baseline (Day 0) to Day 28, Day 56, and Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EF-M2 in people with Rheumatoid Arthritis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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 13 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: From first dose (Day 0) through end of follow-up (Day 112)). The study lists 4 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 16 Jan 2026.