The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants With Refractory B Cell-mediated Autoimmune Diseases

Description

CALiPSO-1 is a Phase 1, multi-centre, dose-finding 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).

Trial Eligibility

Inclusion Criteria: 1. 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. 2. Participants must have current or history of elevated anti-double stranded deoxyribonucleic acid (anti-dsDNA) and/or elevated anti-Smith antibody test. 3. Participants with diabetes or hypothyroidism should have well-controlled disease, with stable medications for at least 4 weeks prior to Screening. SLE-specific Inclusion Criteria 1. Participants who have: 1. 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 2. 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 LN-specific Inclusion Criteria 1.a. Participants with active, biopsy-proven, proliferative LN Class III or IV according to the 2018 revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. Biopsy must be within 12 months prior to Screening or during Screening. Exclusion Criteria: 1. Participants on hemodialysis. 2. 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. 3. Participants with BILAG A for neuropsychiatric SLE. 4. Any current, acute, and severe lupus-related flare that needs immediate treatment, such as acute CNS lupus (eg, psychosis, seizure), catastrophic antiphospholipid syndrome, etc. 5. Thromboembolic events within last 12 months. 6. Participants with severe hepatic dysfunction, defined as grade C-Child-Pugh. 7. Diagnosis of drug-induced SLE rather than idiopathic SLE. SLE-specific Exclusion Criteria 1. Participants with a diagnosis of LN Classes III, IV, V, or VI on the most current biopsy according to the 2018 revised ISN/RPS criteria. 2. Participants with either proteinuria \>3 grams per 24 hours (g/ 24 hours), or a urinary protein creatinine ratio (UPCR) of \>3 grams per gram (g/g). 3. Participants with estimated glomerular filtration rate \<45 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (measured by Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) or serum creatinine \>2.5 milligrams per deciliter (mg/dL). LN-specific Exclusion Criteria 1. Participants with predominantly LN Classes V or VI on the most recent biopsy according to the 2018 revised ISN/RPS criteria. 2. Participants with estimated glomerular filtration rate \<30 mL/min/1.73 m\^2 (measured by Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) or serum creatinine \>2.5 mg/dL.

Study Info

Interventions

Locations Recruiting

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