CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

Running, not enrolling · Phase 1

Conditions studied: Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis, SLE Nephritis, ANCA Associated Vasculitis

In brief

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.

Key facts

Study ID

NCT06152172

Run by

David Porter

People needed

24

Starts

2024-08-05

Expected to finish

2027-02-01

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Idiopathic inflammatory myopathy (including dermatomyositis, antisynthetase syndrome, immune mediated necrotizing myopathy, and polymyositis):
• 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:
• Patient global VAS≥3 on a 1-10 scale (Appendix 3).
• Physician's global VAS ≥3 on a 1-10 scale (Appendix 4).
• Global extramuscular activity score ≥2 cm (Appendix 5).
• Elevation of at least one of the muscle enzymes (CK, AST, ALT, aldolase, LDH) >1.5 times upper limit of normal (Appendix 6).
• HAQ-DI ≥0.25 (Appendix 7).
• Active disease as per one of the following:
• Creatine kinase ≥4×ULN.
• Active rashes of dermatomyositis such that CDASI-activity ≥6 (Appendix 8).
• Evidence on MRI of active myositis within last 6 months.
• Evidence on EMG of active myositis within last 6 months.
• Muscle biopsy evidence of active myositis within last 6 months
• 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.
• Table 3. Pre specified List of Autoantibodies
• Myositis-specific: Target Antigen
• Anti-Jo-1: Histidyl-tRNA synthetase
• Anti-EJ: Glycyl-tRNA synthetase
• Anti-PL-7: Threonyl-tRNA synthetase
• Anti-OJ: Isoleucyl-tRNA synthetase
• Anti-PL-12: Alanyl-tRNA synthetase
• Anti-Mi-2: Nucleosome remodeling deacetylase complex
• Anti-TIF1 gamma; Transcription intermediary factor 1
• Anti-MDA5: Melanoma differentiation associated protein 5

You may not qualify if…

• Autoimmune Disease-Related Exclusion Criteria
• Idiopathic inflammatory myopathy:
• 1a. Evidence of any of the following:
• Severe muscle damage as per one of the following criteria:
• Myositis Global Damage Index (MDI) ≥5.
• Severe proximal muscle atrophy of upper or lower extremity on MRI.
• Severe proximal muscle atrophy of upper or lower extremity on clinical examination.
• Wheelchair-bound at home.
• MMT-8 of ≤80.
• MDA5-positive rapidly progressing disease (subjects with stable ILD not requiring supplemental oxygen are eligible).
• Findings of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), cancer-associated myositis (myositis diagnosed within 2 years of cancer), drug-induced myopathy, amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease (overlap myositis), except with Sjögren's syndrome.
• Patients with ILD requiring O2 therapy and/or FVC ≤45% of predicted.
• Generalized, severe musculoskeletal or neuro-muscular conditions other than IIM that prevent a sufficient assessment of the patient by the physician.
• Diffuse cutaneous systemic sclerosis:
• b. Subject with any of the following:
• Patients with ILD with any of the following
• Requiring O2 therapy and/or FVC ≤45% of predicted or DLCO ≤40% of predicted at screening
• Evidence of PAH as defined as estimated RVSP or ≥45 mmHg or right atrial or ventricular enlargement or dilatation, unless subsequent RHC shows no PAH.
• PAH on right heart catheterization requiring PAH specific treatment.
• Active bleeding related to gastric antral vascular ectasia (GAVE) in past 6 months.
• Gastrointestinal dysmotility requiring total parenteral nutrition (TPN).
• Renal crisis within 1 year prior to enrollment.
• Pericardial tamponade within 6 months prior to enrollment.
• Active infection of a digital ulcer within 3 months prior to enrollment.
• Current gangrene of a digit

Where it is running

• Hospital of the Universithy of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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