Safety, Tolerability and Efficacy of GcMAF in Patients With Chronic Inflammatory Diseases

NCT06877364 | Completed Phase 1

• 1 other identifier: SW024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammation

Keywords

macrophages; inflamation regulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  16 Week

Secondary Outcomes (3)

• Change in Serum C-Reactive Protein (CRP)

  16 weeks

• Change in Erythrocyte Sedimentation Rate (ESR)

  16 weeks

• Change in SF-36 Quality of Life Score

  16 weeks

Study Arms (2)

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).

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.

Other: Placebo Injection (Saline)

Interventions

GcMAF BIOLOGICAL

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.

Experimental: GcMAF

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.

Placebo Comparator: Saline Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Study Sites (1)

Center For New Medical Technologies

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Inflammation

Interventions

vitamin D-binding protein-macrophage activating factor; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: September 1, 2025
• Primary Completion: September 3, 2025
• Study Completion: November 3, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)