A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

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/A

Clinical Study ID

NCT05263817
CD19/BCMA-005
  • All Genders

Study Summary

A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. 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.
  1. After glucocorticoids, cyclophosphamide or methotrexate treatments there are stillrelapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.
  2. 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:
  1. History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascularischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such assevere arrhythm ia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
  7. Those who have used any gene therapy products before.
  8. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
  9. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
  10. Those who suffer from other uncontrolled diseases are not suitable to join thestudy;
  11. HIV infection;
  12. 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

POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis and other diseases may only show local pathological damage or systemic lesions. If they are not diagnosed and treated in time or poorly controlled, they will progress as the course of the disease progresses. Risk of disability or even death.

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

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