Last updated: February 21, 2022
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Dermatomyositis (Connective Tissue Disease)
Circulation Disorders
Vascular Diseases
Treatment
N/AClinical Study ID
NCT05263817
CD19/BCMA-005
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed with POEMS syndrome, amyloidosis, autoimmune hemolytic anemia,vasculitis, and the curative effect of conventional hormones, radiotherapy andchemotherapy, protease inhibitors is not good and (or) no effective treatment means.
- After glucocorticoids, cyclophosphamide or methotrexate treatments there are stillrelapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.
- Estimated survival time> 12 weeks; 4. Patients had a negative urine pregnancy testbefore the start of administration and agreed to take effective contraceptive measuresduring the test period until the last follow-up; 5. Patients or their legal guardiansvolunteer to participate in the study and sign the informed consent.
Exclusion
Exclusion Criteria:
- Subjects with any of the following exclusion criteria were not eligible for thistrial:
- History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascularischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such assevere arrhythm ia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infectionand 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-stimulationsignal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join thestudy;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients orinterfere with the test results.
Study Design
Total Participants: 75
Study Start date:
October 08, 2021
Estimated Completion Date:
October 01, 2024
Study Description
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

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