A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases (NCT06255028) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
United States6 participantsStarted 2025-02-06
Plain-language summary
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic lupus erythematosus (SLE) with or without lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (DcSSc).
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. 17 years of age and older.
✓. Participants must have adequate organ function as defined in the protocol.
✓. Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus for at least 6 months.
✓. Participants must have current or history of elevated anti-double stranded deoxyribonucleic acid (anti-dsDNA), anti-Smith, anti-histone, and/or anti-nucleosome antibodies.
✓. A Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥8 (including at least 4 points from non-laboratory assessments; excluding alopecia, mucosal ulcers, and fever) and at least 2 British Isles Lupus Assessment Group B (BILAG B) organ system scores and/or
✓. At least one British Isles Lupus Assessment Group A (BILAG A) organ system score, including cardiac (peri- or myocarditis), respiratory (pleuritis or lung involvement), vascular and renal.
✓. For Dermatomyositis (DM), meet 2017 American College of Rheumatology/European Alliance of Associations of Rheumatology (ACR/EULAR) diagnostic criteria for definite or probable DM.
✓. For participants with anti-synthetase syndrome (ASyS), meet Classification Criteria for anti-synthetase syndrome per the Classification Criteria for Anti-Synthetase Syndrome (CLASS) Project with a positive tRNA synthetase autoantibody at Screening or per medical history.
Exclusion criteria
✕. Participants on hemodialysis.
What they're measuring
1
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Timeframe: Up to 29 days
2
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days after first CNTY-101 infusion
3
Recommended Phase 2 Regimen (RP2R) of CNTY-101 With/Without IL-2 (With or Without Optimized LDC)
Timeframe: Up to 3 months after the first CNTY-101 infusion
✕. Other comorbid conditions as defined in the protocol.
✕. History of allogeneic bone marrow/hematopoietic stem cell or solid organ transplant at any time. History of autologous stem cell transplant \>100 days prior to Screening is allowed.
✕. Recent or clinically significant central nervous system (CNS) disease, including but not limited to cerebrovascular accident, epilepsy, severe brain injury, dementia, Parkinson's disease, cerebellar disease, seizures, organic brain syndrome, lupus headache, or psychosis at any time prior to study.
✕. Thromboembolic events within last 12 months.
✕. Participants with severe hepatic dysfunction, defined as grade C-Child-Pugh.
✕. Participants with BILAG A for neuropsychiatric SLE.
✕. Any current, acute, and severe lupus-related flare that needs immediate treatment.