MedTrace Logo

EF-M2 (Immutalon) Multiple Ascending Dose Study in Moderate-to-Severe Rheumatoid Arthritis

NCT07349420 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-16

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

EF-M2

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).

Sponsors & Collaborators

  • Activator MAF, LLC

    collaborator UNKNOWN

  • Center for New Medical Technologies, Novosibirsk, Russia

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2025-10-05
Completion
2025-12-06

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349420 on ClinicalTrials.gov