Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06249438

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Led by RenJi Hospital · Updated on 2025-07-25

30

Participants Needed

1

Research Sites

832 weeks

Total Duration

On this page

Sponsors

R

RenJi Hospital

Lead Sponsor

A

AbelZeta Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy

CONDITIONS

Official Title

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years at the time of signing the informed consent form
  • Diagnosed with SLE, IMNM, NMOSD, MS, MG, or SSc for at least 6 months according to recognized criteria
  • Active or relapsed disease after at least 8 weeks of stable standard therapy with at least two immunosuppressants, biologics, or disease-modifying drugs
  • Adequate bone marrow, coagulation, heart, lung, liver, and kidney function
Not Eligible

You will not qualify if you...

  • Positive for Hepatitis B, Hepatitis C, HIV, Treponema Pallidum, CMV DNA, or EBV DNA
  • Uncontrolled active infection
  • Received live vaccine within 4 weeks before signing the informed consent form
  • History of major organ or bone marrow/hematopoietic stem cell transplantation
  • Severe cardiovascular disease within 6 months before screening
  • Grade 2 or higher bleeding within 30 days before screening or requiring long-term anticoagulant treatment
  • Inadequate washout period from previous treatments
  • Previous treatment with CAR-T cells or genetically modified T cell therapies
  • Pregnant or lactating women
  • Severe central nervous system diseases or pathological changes
  • History of cancer within 5 years before signing the informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, China, 200001

Actively Recruiting

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Research Team

N

Nan Shen, MD & PhD

CONTACT

H

Huihua Ding, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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