CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (NCT06152172) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
United States24 participantsStarted 2024-08-05
Plain-language summary
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of probable or definite (\>55%) idiopathic inflammatory myopathy, including dermatomyositis, anti-synthetase myopathy, immune-mediated necrotizing myopathy (including anti-HMGCoR-myopathy, anti-SRP myopathy), polymyositis, according to the 2017 ACR/EULAR Classification Criteria for idiopathic inflammatory myopathies (Lundberg, Tjarnlund et al. 2017).
✓. Disease severity and minimal core set measure criteria: MMT-8 score \<136/150, with at least 2 other abnormal core set measures (CSMs) from the following:
✓. Active disease as per one of the following:
✓. Positive, at screening or by documented medical history, for one myositis-specific per pre specified list (Table 3), except for patients with DM who need not have a positive test for a myositis-specific antibody.
✓. Refractory disease: subject with previous failure (or intolerance) to glucocorticoids and at least two non-glucocorticoids immunosuppressive therapies. An adequate trial of medication defined as at least 12 weeks of therapy or intolerance/adverse reaction necessitating discontinuation.
✓. Classified as systemic sclerosis according to the 2013 ACR/EULAR classification criteria, with a total score of ≥9.
✓. Clinical disease as follows:
✓. Clinical diagnosis of SLE consistent with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
✕. d. Subject with any of the following acute manifestations of ANCA-associated vasculitis:
✕. Prior treatment with cellular immunotherapy (eg, CAR T) or gene therapy product directed at any target.
✕. Positive hepatitis B surface antigen (HBsAg) and hepatitis C serology confirmed by polymerase chain reaction (PCR) (except hepatitis C cured with pharmacotherapy); subjects who are HBsAg negative and hepatitis B core antibody (HBc) positive with no detectable DNA will be allowed into the study but will require regular monitoring of hepatitis B virus (HBV) DNA.
✕. Positive serology for human immunodeficiency virus (HIV).
✕. Primary immunodeficiency.
✕. History of other autoimmune disorders other than the target disease requiring immunosuppressve therapies.