Actively Recruiting

Phase 1
Age: 5Years +
All Genders
NCT06934447

Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE

Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-04-25

18

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

T

The Children's Hospital of Zhejiang University School of Medicine

Lead Sponsor

C

Chongqing Precision Biotech Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.

CONDITIONS

Official Title

Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE

Who Can Participate

Age: 5Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 5 years or older
  • Diagnosed with SLE according to 2019 EULAR/ACR criteria with moderate to severe disease despite at least 3 months of high-dose glucocorticoids and other immunosuppressants, or intolerant to standard treatments
  • SLEDAI 2K score of 8 points or higher
  • Adequate organ function: cardiac ejection fraction 55% or higher with normal ECG, kidney function eGFR 30 mL/min/1.73m2 or higher, liver enzymes within 3 times upper limit of normal, total bilirubin less than twice upper limit of normal, lung function with oxygen saturation 92% or higher
  • No prior CAR-T therapy or poor response after previous CAR-T targeting CD19
  • Eligible for leukapheresis or blood collection with no contraindications
  • Negative pregnancy test for females of childbearing age and agreement to use contraception for one year after treatment
  • Participant or guardian agrees to participate and signs informed consent
Not Eligible

You will not qualify if you...

  • Central nervous system lupus requiring intervention within 60 days
  • Severe acute nephritis requiring or having received renal replacement therapy within 3 months, or likely kidney disease needing high dose steroids or immunosuppressants within 3 months
  • History of congenital heart disease, recent heart attack within 6 months, severe arrhythmias, moderate to large pericardial effusion, serious myocarditis, or unstable vital signs requiring hypertensive drugs
  • Other diseases needing long-term high-dose steroids or immunosuppressants
  • Uncontrollable or active infection requiring systemic treatment within 1 week
  • History of organ or hematopoietic stem cell transplant or grade 2 or higher graft-versus-host disease within 2 weeks
  • Positive tests for hepatitis B or C with high viral load, HIV, syphilis, or cytomegalovirus
  • Received live vaccine within 4 weeks
  • Positive pregnancy test
  • Previous or concurrent malignancy
  • Participation in another clinical study within 1 month
  • Any condition deemed unsuitable by investigators

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

hildren's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310052

Actively Recruiting

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Research Team

J

Jianhua Mao, MD

CONTACT

X

Xue He

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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