Gender
All
Age Group
18 Years to 75 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Age ≥18 and ≤75
- A clinical diagnosis of IIM, based on the 2017 The European League Against
Rheumatism/American College of Rheumatology classification criteria
- Diagnosis of DM, ASyS, IMNM based on the presence of serum myositis-specific
antibodies
- Evidence of active disease, despite prior or current treatment with standard of care
treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or
active disease on muscle biopsy, magnetic resonance imaging (MRI), or
electromyography
- Presence of muscle weakness
Exclusion Criteria:
- Contraindication to leukapheresis
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide
or any of their metabolites
- Active infection requiring medical intervention at screening
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or
cerebral disease, including severe and uncontrolled infections, such as sepsis and
opportunistic infections.
- Concomitant medical conditions that, in the opinion of the investigator, might place
the subject at unacceptable risk for participation in this study, interfere with the
assessment of the effects or safety of the investigational product or with the study
procedures
- Significant lung or cardiac impairment
- Previous CAR T cell therapy
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell
transplant