RecruitingEarly Phase 1NCT07193810

A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

Exploratory Clinical Study on the Safety and Preliminary Efficacy of CC312 in the Treatment of Relapsed/Refractory Autoimmune Diseases

Sponsor

CytoCares Inc

Enrollment

6 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

SLE - Systemic Lupus Erythematosus SSc-Systemic Sclerosis IIM- Idiopathic Inflammatory Myopathies

Summary

This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CC312 for people with iim- idiopathic inflammatory myopathies, sle - systemic lupus erythematosus, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCC312

The priming dose of CC312 will be administered intravenously on Day -3, followed by safety and tolerability evaluations on Day -1 (3 days post-first dose). The first therapeutic dose of CC312 will be administered on Day 1, with subsequent doses administered on Day 4, 8, and 11. Corresponding safety and tolerability assessments will be performed with each dose. Based on the evaluation of clinical efficacy, B-cell depletion, and safety/tolerability profile at the end of Day 14, the dose for the subsequent therapeutic dosing will be determined (maintained or escalated). Thereafter, therapeutic dosing will be administered on Days 15, 18, 22, and 25, accompanied by scheduled safety and tolerability assessments.