InflammationPhase 1/2NCT06877364
Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases
A Phase 1/2 study testing GcMAF in people with Inflammation, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This study, titled "A Multicenter Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases" will investigate Gc Macrophage Activating Factor, a protein derived by enzymatic deglycosylation of vitamin D-binding protein. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation
- What is being tested?
- GcMAF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2025to 3 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, informed consent.
- Confirmed diagnosis of a chronic inflammatory disease (e.g., moderate rheumatoid arthritis or chronic cystitis, or another validated nosology) according to recognized criteria.
- Insufficient effect or intolerance of standard anti-inflammatory therapy (NSAIDs, GCS, etc.).
- Ability to comply with the study protocol.
Who cannot join
- Pregnancy, lactation (lack of safety data in this group).
- Severe systemic diseases (liver/renal failure, severe cardiovascular diseases, uncontrolled arterial hypertension).
- Active serious infections (HIV, tuberculosis, hepatitis B/C in the active phase).
- Previous participation in other experimental studies < 3 months ago.
- Severe allergy to protein components of the drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase I and II Clinical Study on Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases
This study, titled "A Multicenter Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases" will investigate Gc Macrophage Activating Factor, a protein derived by enzymatic deglycosylation of vitamin D-binding protein. GcMAF activates macrophages and dendritic cells, modulates M1/M2 profiles, and shows anti-inflammatory effects. Phase I (open-label, dose-escalation) will assess safety, tolerability, and determine a Recommended Dose (RD). Phase II (randomized, double-blind, placebo-controlled) will evaluate efficacy and further confirm safety in a larger patient population with conditions such as moderate rheumatoid arthritis or chronic cystitis, refractory to standard therapies.
Read the detailed description
This trial is designed to evaluate GcMAF, an immunomodulatory protein generated from vitamin D-binding protein (DBP) via specific enzymatic deglycosylation, in adults (≥18 years) with a confirmed chronic inflammatory disease (e.g., moderate rheumatoid arthritis, chronic cystitis) who have experienced inadequate response or intolerance to standard anti-inflammatory treatments (NSAIDs, corticosteroids, etc.). GcMAF's primary mechanism of action involves activating macrophages and dendritic cells, regulating cytokine production, and potentially offering anti-inflammatory as well as antitumor benefits, as indicated in preclinical studies on animal models with conditions such as adjuvant arthritis and hemorrhagic cystitis.
The study will be conducted in two phases. Phase I is an open-label, dose-escalation investigation comprising 3-4 cohorts receiving increasing doses of GcMAF (administered subcutaneously or intramuscularly). The primary objectives for Phase I are to determine the safety profile, tolerability, and maximum tolerated dose (MTD) or Recommended Dose (RD). This will involve continuous safety monitoring, assessment of adverse events (AEs) using CTCAE criteria, and evaluation of lab parameters (hematology, biochemistry, inflammatory markers). Secondary endpoints in Phase I include preliminary efficacy measures (changes in CRP, ESR, cytokines, and disease-activity scores) and (Cmax, Tmax, AUC, T½), along with possible measurement of antibodies to GcMAF.
Upon establishing the RD in Phase I, Phase II will be a randomized, double-blind, placebo-controlled trial enrolling approximately 60-120 patients. They will be allocated (1:1 or 1:1:1 if multiple GcMAF doses are tested) to receive either GcMAF (RD) or placebo for 12-16 weeks, followed by a 4-8-week observation period. The key inclusion criteria stipulate adult patients with documented chronic inflammatory disease and the ability to adhere to the protocol. Exclusion criteria include pregnancy or lactation, severe systemic illnesses (e.g., liver/kidney failure), active serious infections (HIV, TB, or active hepatitis B/C), recent participation in other experimental studies (<3 months), and hypersensitivity to protein products.
Phase II primary endpoints focus on clinical efficacy, measured by validated scores (e.g., DAS28 for rheumatoid arthritis, symptom indices for cystitis) and the proportion of patients achieving clinically significant improvement (e.g., DAS28 improvement ≥1.2 points). Secondary endpoints include ongoing safety assessments, laboratory markers of inflammation (CRP, ESR, cytokine profile), pharmacodynamic data (such as M1/M2 macrophage ratio), and patient-reported outcomes (e.g., SF-36, HAQ-DI). Statistical analyses will include descriptive methods in Phase I for safety and tolerability, and for Phase II comparative tests (t-test, ANOVA, or nonparametric equivalents) for continuous data and chi-square or Fisher's exact test for categorical response rates. Ultimately this trial seeks to confirm whether GcMAF offers a clinically meaningful reduction of inflammatory disease activity while maintaining an acceptable safety profile.
- Conditions
- Inflammation
- Being tested
- GcMAF, Placebo Injection (Saline)
- Keywords
- macrophages, inflamation regulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GcMAFBiological
GcMAF is an immunomodulatory protein derived from vitamin D-binding protein via enzymatic deglycosylation. In this study, GcMAF will be administered (e.g., subcutaneously) once or twice-weekly for 12-16 weeks, followed by a 4-8-week observation period. The primary objectives include assessing clinical efficacy in chronic inflammatory conditions and confirming safety. GcMAF activates macrophages and dendritic cells, modulates M1/M2 profiles, and may reduce inflammatory markers such as CRP and ESR.
Placebo Injection (Saline)Other
Participants in the placebo arm will receive a visually matching injection of normal saline (placebo) on the same schedule as the GcMAF arm (e.g., once or twice-weekly for 12-16 weeks). This allows for double-blind comparison of safety and efficacy endpoints. The placebo is designed to be identical in appearance and administration route to maintain blinding for investigators and participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: GcMAF | Experimental | This arm includes patients receiving GcMAF at the recommended dose (determined in the open-label, dose-escalation Phase I portion of the study). GcMAF will be administered (e.g., subcutaneously) once or twice-weekly for approximately 12 - 16 weeks in the randomized Phase II portion. Efficacy will be measured using validated clinical scales (e.g., DAS28 for rheumatoid arthritis) and laboratory markers (CRP, ESR, etc.). Safety and tolerability will be monitored throughout the treatment period and in a follow-up phase (4 - 8 weeks). Receives: Biological: GcMAF |
| Placebo Comparator: Saline Injection | Placebo comparator | This arm includes patients receiving a placebo injection (e.g., saline) under the same schedule (once or twice-weekly for 12-16 weeks) in the randomized Phase II portion of the study. Participants and investigators will be blinded to the treatment assignment. Clinical outcomes and safety profiles will be compared with those of the GcMAF arm to evaluate efficacy and confirm the overall safety of GcMAF. Receives: Other: Placebo Injection (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (Safety Assessment)
This outcome measures the incidence, severity, and type of treatment-emergent adverse events (AEs) associated with GcMAF administration, including any serious adverse events (SAEs). Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), which rates severity from Grade 1 (mild) to Grade 5 (death related to AE). A higher count of severe events indicates a worse safety profile.
Measured: 4 weeks
Change in DAS28 Score
The Disease Activity Score 28 (DAS28) is used to evaluate rheumatoid arthritis disease activity, though it can be adapted for other chronic inflammatory conditions as applicable. DAS28 ranges from 0.0 to 9.4, where higher scores indicate greater disease activity. A decrease in DAS28 score from baseline represents clinical improvement. For example, a DAS28 score under 2.6 is considered remission, while above 5.1 indicates high disease activity.
Measured: 16 Week
Secondary outcomes (3)
Change in Serum C-Reactive Protein (CRP)
CRP is a laboratory measure of inflammation, reported in mg/L. Higher CRP values generally indicate more inflammation. This outcome will compare CRP levels at baseline versus the end of the active treatment period to assess the anti-inflammatory effect of GcMAF. A lower CRP at follow-up suggests improvement.
Measured: 16 weeks
Change in Erythrocyte Sedimentation Rate (ESR)
ESR (mm/hr) is another indicator of systemic inflammation; higher values typically reflect more active inflammation. This outcome measure tracks the difference in ESR from baseline to post-treatment, allowing comparison between the GcMAF arm and placebo. A decrease in ESR indicates improvement.
Measured: 16 weeks
Change in SF-36 Quality of Life Score
The 36-Item Short Form Survey (SF-36) measures overall health status across multiple domains (physical functioning, pain, vitality, mental health, etc.). Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. The total SF-36 score is often reported as two main components (Physical and Mental), each ranging from 0 (worst) to 100 (best). An increase in SF-36 scores indicates an improvement in quality of life.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Sep 2025
- Primary completion3 Sep 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877364
- Sponsor's protocol ID
- SW024
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2025
- Last updated
- 16 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase I and II Clinical Study on Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT06877364
- Acronym / sponsor ID
- SW024
- Conditions
- Inflammation
- Keywords
- macrophages, inflamation regulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 14 Mar 2025 (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 study, titled "A Multicenter Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases" will investigate Gc Macrophage Activating Factor, a protein derived by enzymatic deglycosylation of vitamin D-binding protein. GcMAF activates macrophages and dendritic cells, modulates M1/M2 profiles, and shows anti-inflammatory effects. Phase I (open-label, dose-escalation) will assess safety, tolerability, and determine a Recommended Dose (RD). Phase II (randomized, double-blind, placebo-controlled) will evaluate efficacy and further confirm safety in a larger patient population with conditions such as moderate rheumatoid arthritis or chronic cystitis, refractory to standard therapies.
Detailed description
This trial is designed to evaluate GcMAF, an immunomodulatory protein generated from vitamin D-binding protein (DBP) via specific enzymatic deglycosylation, in adults (≥18 years) with a confirmed chronic inflammatory disease (e.g., moderate rheumatoid arthritis, chronic cystitis) who have experienced inadequate response or intolerance to standard anti-inflammatory treatments (NSAIDs, corticosteroids, etc.). GcMAF's primary mechanism of action involves activating macrophages and dendritic cells, regulating cytokine production, and potentially offering anti-inflammatory as well as antitumor benefits, as indicated in preclinical studies on animal models with conditions such as adjuvant arthritis and hemorrhagic cystitis.
The study will be conducted in two phases. Phase I is an open-label, dose-escalation investigation comprising 3-4 cohorts receiving increasing doses of GcMAF (administered subcutaneously or intramuscularly). The primary objectives for Phase I are to determine the safety profile, tolerability, and maximum tolerated dose (MTD) or Recommended Dose (RD). This will involve continuous safety monitoring, assessment of adverse events (AEs) using CTCAE criteria, and evaluation of lab parameters (hematology, biochemistry, inflammatory markers). Secondary endpoints in Phase I include preliminary efficacy measures (changes in CRP, ESR, cytokines, and disease-activity scores) and (Cmax, Tmax, AUC, T½), along with possible measurement of antibodies to GcMAF.
Upon establishing the RD in Phase I, Phase II will be a randomized, double-blind, placebo-controlled trial enrolling approximately 60-120 patients. They will be allocated (1:1 or 1:1:1 if multiple GcMAF doses are tested) to receive either GcMAF (RD) or placebo for 12-16 weeks, followed by a 4-8-week observation period. The key inclusion criteria stipulate adult patients with documented chronic inflammatory disease and the ability to adhere to the protocol. Exclusion criteria include pregnancy or lactation, severe systemic illnesses (e.g., liver/kidney failure), active serious infections (HIV, TB, or active hepatitis B/C), recent participation in other experimental studies (<3 months), and hypersensitivity to protein products.
Phase II primary endpoints focus on clinical efficacy, measured by validated scores (e.g., DAS28 for rheumatoid arthritis, symptom indices for cystitis) and the proportion of patients achieving clinically significant improvement (e.g., DAS28 improvement ≥1.2 points). Secondary endpoints include ongoing safety assessments, laboratory markers of inflammation (CRP, ESR, cytokine profile), pharmacodynamic data (such as M1/M2 macrophage ratio), and patient-reported outcomes (e.g., SF-36, HAQ-DI). Statistical analyses will include descriptive methods in Phase I for safety and tolerability, and for Phase II comparative tests (t-test, ANOVA, or nonparametric equivalents) for continuous data and chi-square or Fisher's exact test for categorical response rates. Ultimately this trial seeks to confirm whether GcMAF offers a clinically meaningful reduction of inflammatory disease activity while maintaining an acceptable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: GcMAF | Experimental | Biological: GcMAFThis arm includes patients receiving GcMAF at the recommended dose (determined in the open-label, dose-escalation Phase I portion of the study). GcMAF will be administered (e.g., subcutaneously) once or twice-weekly for approximately 12 - 16 weeks in the randomized Phase II portion. Efficacy will be measured using validated clinical scales (e.g., DAS28 for rheumatoid arthritis) and laboratory markers (CRP, ESR, etc.). Safety and tolerability will be monitored throughout the treatment period and in a follow-up phase (4 - 8 weeks). |
| Placebo Comparator: Saline Injection | Placebo comparator | Other: Placebo Injection (Saline)This arm includes patients receiving a placebo injection (e.g., saline) under the same schedule (once or twice-weekly for 12-16 weeks) in the randomized Phase II portion of the study. Participants and investigators will be blinded to the treatment assignment. Clinical outcomes and safety profiles will be compared with those of the GcMAF arm to evaluate efficacy and confirm the overall safety of GcMAF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, informed consent.
- Confirmed diagnosis of a chronic inflammatory disease (e.g., moderate rheumatoid arthritis or chronic cystitis, or another validated nosology) according to recognized criteria.
- Insufficient effect or intolerance of standard anti-inflammatory therapy (NSAIDs, GCS, etc.).
- Ability to comply with the study protocol.
Key exclusion criteria (5 listed)
- Pregnancy, lactation (lack of safety data in this group).
- Severe systemic diseases (liver/renal failure, severe cardiovascular diseases, uncontrolled arterial hypertension).
- Active serious infections (HIV, tuberculosis, hepatitis B/C in the active phase).
- Previous participation in other experimental studies < 3 months ago.
- Severe allergy to protein components of the drug.
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 |
|---|---|---|
| GcMAFGcMAF is an immunomodulatory protein derived from vitamin D-binding protein via enzymatic deglycosylation. In this study, GcMAF will be administered (e.g., subcutaneously) once or twice-weekly for 12-16 weeks, followed by a 4-8-week observation period. The primary objectives include assessing clinical efficacy in chronic inflammatory conditions and confirming safety. GcMAF activates macrophages and dendritic cells, modulates M1/M2 profiles, and may reduce inflammatory markers such as CRP and ESR. | Biological | Experimental: GcMAF |
| Placebo Injection (Saline)Participants in the placebo arm will receive a visually matching injection of normal saline (placebo) on the same schedule as the GcMAF arm (e.g., once or twice-weekly for 12-16 weeks). This allows for double-blind comparison of safety and efficacy endpoints. The placebo is designed to be identical in appearance and administration route to maintain blinding for investigators and participants. | Other | Placebo Comparator: Saline Injection |
Primary outcome
Number of Participants with Treatment-Emergent Adverse Events (Safety Assessment)
Time frame: 4 weeks
This outcome measures the incidence, severity, and type of treatment-emergent adverse events (AEs) associated with GcMAF administration, including any serious adverse events (SAEs). Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), which rates severity from Grade 1 (mild) to Grade 5 (death related to AE). A higher count of severe events indicates a worse safety profile.
Change in DAS28 Score
Time frame: 16 Week
The Disease Activity Score 28 (DAS28) is used to evaluate rheumatoid arthritis disease activity, though it can be adapted for other chronic inflammatory conditions as applicable. DAS28 ranges from 0.0 to 9.4, where higher scores indicate greater disease activity. A decrease in DAS28 score from baseline represents clinical improvement. For example, a DAS28 score under 2.6 is considered remission, while above 5.1 indicates high disease activity.
3 secondary outcomes
Change in Serum C-Reactive Protein (CRP)
Time frame: 16 weeks
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: 16 weeks
Change in SF-36 Quality of Life Score
Time frame: 16 weeks
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 Dec 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.
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 GcMAF in people with Inflammation, 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 4 inclusion and 5 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 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Treatment-Emergent Adverse Events (Safety Assessment) (time frame: 4 weeks). The study lists 2 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 Dec 2025.