A Study of CNTY-101 in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

— CALiPSO-1  

Official title:

The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants With Moderate to Severe Systemic Lupus Erythematosus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255028
• Other study ID #: CNTY-101-151-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 2024
• Est. completion date: August 2028

Study information

• Verified date: February 2024
• Source: Century Therapeutics, Inc.
• Contact: Nikolaus Trede
• Phone: 8885067670
• Email: calipso-1_clinicalteam[@]centurytx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CALiPSO-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety and efficacy of CNTY-101 in participants with moderate to severe systemic lupus erythematosus.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

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 elevated anti- double stranded deoxyribonucleic acid (anti-dsDNA) and/or elevated anti-Smith antibody test at Screening (a single retest of previously positive participants who were negative at screening will be allowed).

3. Participants with diabetes or hypothyroidism should have well-controlled disease, with stable medications for at least 4 weeks prior to screening.

4. Participants who despite at least 2 lines of prior standard immunosuppressive therapies for =12 weeks 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

Exclusion Criteria:

1. Unable to washout prohibited or maintain stable allowed SLE therapy for 4 weeks prior to LDC therapy.

2. Participants on hemodialysis.

3. Participants with active lupus nephritis (prior history of biopsy-documented International Society of Nephrology/Renal Pathology Society Class VI Lupus Nephritis).

4. 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.

5. Participants with BILAG A for neuropsychiatric SLE.

6. Thromboembolic events within last 12 months.

7. Participants with severe hepatic dysfunction, defined as grade C-Child-Pugh.

8. Diagnosis of drug-induced SLE rather than idiopathic SLE.

9. Participants with either proteinuria >3 grams per day (g/day), or a urinary protein creatinine ratio (UPCR) of >3 grams per gram (g/g). At least 2 measurements of proteinuria or UPCR over the past 6 months is required to confirm control of renal disease.

10. Study participant with chronic kidney failure stage 4, manifested by 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).

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• CNTY-101
CNTY-101 cells for intravenous (IV) infusion
• IL-2
IL-2 subcutaneous (SC) injection

Drug:
• Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Century Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs		Up to 29 days
Primary	Percentage of Participants With Dose Limiting Toxicities (DLTs)		Up to 28 days after first CNTY-101 infusion
Primary	Recommended Phase 2 Regimen (RP2R) With/Without IL-2		Up to 29 days
Secondary	Percentage of Participants With TEAEs and Serious Adverse Events (SAEs)		Day 1 up to 1 year
Secondary	Percentage of Participants With Clinically Significant Laboratory Abnormalities and Severity of Laboratory Abnormalities		Day 1 up to 1 year
Secondary	Percentage of Participants With Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Severity of CRS and ICANS		Day 1 up to 1 year
Secondary	Percentage of Participants With SLE - Responder Index 4 (SRI-4) Response		Up to 1 year
Secondary	Percentage of Participants With Low Disease Activity by Lupus Low Disease Activity State (LLDAS)		Up to 1 year
Secondary	Percentage of Participants in Remission as Measured by Definitions of Remission in SLE (DORIS) Remission		Up to 1 year