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A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

NCT07193810 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

CC312

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.

Sponsors & Collaborators

  • CytoCares Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2027-09-29
Completion
2027-09-29

Countries

  • China

Study Locations

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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 NCT07193810 on ClinicalTrials.gov