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A Study of CNTY-101 in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) (CALiPSO-1)

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ClinicalTrials.gov Identifier: NCT06255028
Recruitment Status : Not yet recruiting
First Posted : February 12, 2024
Last Update Posted : February 12, 2024
Sponsor:
Information provided by (Responsible Party):
Century Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: CNTY-101 Biological: IL-2 Drug: Lymphodepleting Chemotherapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Phase

Lymphodepleting chemotherapy (LDC) will be followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental human recombinant interleukin 2 (IL-2).

After completion of Cycle 1, CNTY-101 (without preceding LDC), administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2.

 Biological: CNTY-101
CNTY-101 cells for intravenous (IV) infusion

Biological: IL-2
IL-2 subcutaneous (SC) injection

Drug: Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Experimental: Part 2: Dose Expansion Phase
Treatment using the recommended phase 2 regimen (RP2R) confirmed during Part 1 of the study.
 Biological: CNTY-101
CNTY-101 cells for intravenous (IV) infusion

Biological: IL-2
IL-2 subcutaneous (SC) injection

Drug: Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs [ Time Frame: Up to 29 days ]
  2. Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days after first CNTY-101 infusion ]
  3. Recommended Phase 2 Regimen (RP2R) With/Without IL-2 [ Time Frame: Up to 29 days ]

Secondary Outcome Measures :
  1. Percentage of Participants With TEAEs and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to 1 year ]
  2. Percentage of Participants With Clinically Significant Laboratory Abnormalities and Severity of Laboratory Abnormalities [ Time Frame: Day 1 up to 1 year ]
  3. Percentage of Participants With Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Severity of CRS and ICANS [ Time Frame: Day 1 up to 1 year ]
  4. Percentage of Participants With SLE - Responder Index 4 (SRI-4) Response [ Time Frame: Up to 1 year ]
  5. Percentage of Participants With Low Disease Activity by Lupus Low Disease Activity State (LLDAS) [ Time Frame: Up to 1 year ]
  6. Percentage of Participants in Remission as Measured by Definitions of Remission in SLE (DORIS) Remission [ Time Frame: Up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06255028


Contacts
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Contact: Nikolaus Trede 8885067670 calipso-1_clinicalteam@centurytx.com

Sponsors and Collaborators
Century Therapeutics, Inc.
More Information
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Responsible Party: Century Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06255028    
Other Study ID Numbers: CNTY-101-151-01
First Posted: February 12, 2024    Key Record Dates
Last Update Posted: February 12, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Century Therapeutics, Inc.:
CAR iNK
CAR NK
Cellular therapy
Systemic Lupus Erythematosus
 Induced pluripotent stem cell (iPSC)
Anti-CD19 therapy
CNTY-101
Autoimmune disease
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases