UnknownEarly Phase 1

Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases

China75 participantsStarted 2022-02-28

Plain-language summary

A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosed as refractory Crohn disease, ulcerative colitis (collectively called Crohn's disease), and the conventional hormone therapy is not effective and (or) there is no effective treatment:
✓. At least 6 months before screening, diagnosed as Crohn's disease based on typical radiological results and/or typical histology.
✓. In addition to corticosteroids, after the use of immunosuppressive agents (usually azathioprine, methotrexate, and two biological agents (usually infliximab, adalimumab and/or setolizumab), the course of the disease is still Unsatisfactory. Patients should still have relapsed and refractory diseases after glucocorticoid and/or immunosuppressive treatment, or clearly show intolerance/toxicity to these drugs
✓. Diagnosed as refractory dermatomyositis, and conventional hormone therapy is not effective and (or) ineffective treatment methods:
✓. At least 6 months before screening, confirmed or possible dermatomyositis according to Bohan and Peter criteria;
✓. At least it has no response to prednisone and other first-line immunosuppressants (such as methotrexate, mycophenolate mofetil, or azathioprine), or has obvious toxicity or intolerance to these therapies.
✓. Refractory adult STILL disease
✓. Conform the diagnostic criteria for adult STILL disease (according to Yamaguchi et al., J. Rheumatology, 1992);

✕. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
✕. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
✕. Pregnant (or lactating) women;
✕. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
✕. Active infection of hepatitis B virus or hepatitis C virus;
✕. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
✕. Those who have used any gene therapy products before.
✕. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;

Dose-limiting toxicity (DLT)

Timeframe: Baseline up to 28 days after CD7 targeted CAR T-cells infusion

Incidence of treatment-emergent adverse events (TEAEs)

Timeframe: Up to 2 years after CD7 targeted CAR T-cells infusion

NCT IDNCT05239702

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

He Huang, PhD

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosed as refractory Crohn disease, ulcerative colitis (collectively called Crohn's disease), and the conventional hormone therapy is not effective and (or) there is no effective treatment:
✓. At least 6 months before screening, diagnosed as Crohn's disease based on typical radiological results and/or typical histology.
✓. In addition to corticosteroids, after the use of immunosuppressive agents (usually azathioprine, methotrexate, and two biological agents (usually infliximab, adalimumab and/or setolizumab), the course of the disease is still Unsatisfactory. Patients should still have relapsed and refractory diseases after glucocorticoid and/or immunosuppressive treatment, or clearly show intolerance/toxicity to these drugs
✓. Diagnosed as refractory dermatomyositis, and conventional hormone therapy is not effective and (or) ineffective treatment methods:
✓. At least 6 months before screening, confirmed or possible dermatomyositis according to Bohan and Peter criteria;
✓. At least it has no response to prednisone and other first-line immunosuppressants (such as methotrexate, mycophenolate mofetil, or azathioprine), or has obvious toxicity or intolerance to these therapies.
✓. Refractory adult STILL disease
✓. Conform the diagnostic criteria for adult STILL disease (according to Yamaguchi et al., J. Rheumatology, 1992);

✕. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
✕. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
✕. Pregnant (or lactating) women;
✕. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
✕. Active infection of hepatitis B virus or hepatitis C virus;
✕. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
✕. Those who have used any gene therapy products before.
✕. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;