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Active, not recruitingNCT06255028CALiPSO-1Updated Jan 8, 2026

A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases

A Phase 1 interventional study of CNTY-101 and IL-2 in Systemic Lupus Erythematosus, Lupus Nephritis and Idiopathic Inflammatory Myopathies, sponsored by Century Therapeutics, Inc.. Active, not recruiting at 6 sites in United States. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Primary conditionLupus NephritisRegistry: Lupus Erythematosus, SystemicReclassifiedWhy we changed it
Registry
Lupus Erythematosus, Systemic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lupus Nephritis
Why
  1. The study's listed conditions name Lupus Nephritis, a narrower term within Lupus Erythematosus, Systemic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Century Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
17 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Lupus Nephritis
  • Idiopathic Inflammatory Myopathies
  • Diffuse Cutaneous Systemic Sclerosis

Keywords

  • CAR iNK
  • CAR NK
  • Cellular therapy
  • Systemic Lupus Erythematosus
  • SLE
  • Induced pluripotent stem cell (iPSC)
  • Anti-CD19 therapy
  • CNTY-101
  • Autoimmune disease
  • Lupus Nephritis
  • Lupus
  • Idiopathic Inflammatory Myopathies
  • Diffuse Cutaneous Systemic Sclerosis
  • IIM
  • DcSSc
  • Myositis
  • Polymyositis
  • Dermatomyositis
  • Anti-synthetase syndrome
  • Systemic sclerosis
  • Sclerosis
03

In context

Lupus Nephritis Reclassified

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

This study's enrollment of 6 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.

Browse Lupus Nephritis studies →

Lead sponsor

Century Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General Inclusion Criteria:

  1. 17 years of age and older.
  2. Participants must have adequate organ function as defined in the protocol.

SLE/LN-specific 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), anti-Smith, anti-histone, and/or anti-nucleosome antibodies.

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. Participants with active, -proven, proliferative LN Class III or IV, either with or without the presence of class V, 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.

IIM-specific Inclusion Criteria:

1. Classification of IIM (juvenile-onset IIM may be included):

  1. For Dermatomyositis (DM), meet 2017 American College of Rheumatology/European Alliance of Associations of Rheumatology (ACR/EULAR) diagnostic criteria for definite or probable DM.
  2. 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.
  3. For Polymyositis (PM)/ necrotizing myopathy (NM), meet 2017 ACR/ EULAR classification criteria for definite or probable PM/NM and meet one of the following criteria:

i. Positive myositis specific antibody (MSA) at Screening or per medical history or ii. Muscle biopsy at Screening or per medical history available for review

DcSSc-specific Inclusion Criteria:

  1. Meets the 2013 ACR/EULAR criteria for SSc with a total score of ≥9.
  2. Meets criteria for DcSSc, including skin involvement proximal to the elbow and/or knee.
  3. mRSS units ≥15 at Screening; for participants agreeing to biopsy, skin thickening from SSc in the forearm suitable for biopsy.

Exclusion criteria

Exclusion Criteria:

General Exclusion Criteria:

  1. Participants on hemodialysis.
  2. Other comorbid conditions as defined in the protocol.
  3. History of allogeneic bone marrow/hematopoietic stem cell or solid organ transplant at any time. History of stem cell transplant >100 days prior to Screening is allowed.
  4. Recent or 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. Thromboembolic events within last 12 months.
  6. Participants with severe hepatic dysfunction, defined as grade C-.

SLE-specific Exclusion Criteria:

  1. Participants with BILAG A for neuropsychiatric SLE.
  2. Any current, acute, and severe lupus-related flare that needs immediate treatment.
  3. Drug-induced SLE rather than idiopathic SLE.
  4. Participants with a diagnosis of LN Classes III, IV, V, or VI on the most current according to the 2018 revised ISN/RPS criteria.
  5. Participants with estimated (eGFR) \<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 BILAG A for neuropsychiatric SLE.
  2. Any severe lupus-related flare such as acute CNS lupus (eg, psychosis, seizure), catastrophic antiphospholipid syndrome, or rapidly progressive glomerulonephritis that, in the opinion of the Investigator, would cause an unacceptable safety risk.
  3. Drug-induced SLE rather than idiopathic SLE.
  4. Participants with predominantly LN Class V, or Class VI on the most recent biopsy according to the 2018 revised ISN/RPS criteria.
  5. 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.

IIM- specific Exclusion Criteria:

  1. Participants on hemodialysis or estimated glomerular filtration rate \<45 mL/min/1.73 m\^2 (measured by Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) or serum creatinine >2.5 mg/dL.
  2. Have severe muscle damage as defined in the protocol.
  3. Participants with ILD will be excluded if there is severe end stage lung disease as defined in the protocol.

DcSSc-specific Exclusion Criteria

  1. Participants on hemodialysis or estimated glomerular filtration rate \<45 mL/min/1.73 m\^2 (measured by Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) or serum creatinine >2.5 mg/dL.
  2. Participants with ILD will be excluded if there is severe end stage lung disease as defined in the protocol.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Arm A: CNTY-101 in SLE Participants

    During Part 1 (Dose Confirmation Phase), participants with SLE will undergo lymphodepleting chemotherapy (LDC) 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), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the recommended phase 2 regimen (RP2R) confirmed during Part 1.

    Biological: CNTY-101 · Biological: IL-2 · Drug: Lymphodepleting Chemotherapy

  • Experimental
    Arm B: CNTY-101 in LN Participants

    During Part 1 (Dose Confirmation Phase), participants with LN will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

    Biological: CNTY-101 · Biological: IL-2 · Drug: Lymphodepleting Chemotherapy

  • Experimental
    Arm C: CNTY-101 in IIM Participants

    During Part 1 (Dose Confirmation Phase), participants with IIM will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

    Biological: CNTY-101 · Biological: IL-2 · Drug: Lymphodepleting Chemotherapy

  • Experimental
    Arm D: CNTY-101 in DcSSC Participants

    During Part 1 (Dose Confirmation Phase), participants with DcSSC will undergo LDC followed by administration of CNTY-101, administered 3 times over 3 weeks, during Cycle 1 (cycle length = 28 days), alone or with supplemental IL-2. After completion of Cycle 1, CNTY-101 (without preceding LDC), will be administered 3 times over 3 weeks, during Cycle 2 (cycle length = 28 days), alone or with supplemental IL-2. During Part 2 (Dose Expansion Phase), participants will receive treatments using the RP2R confirmed during Part 1.

    Biological: CNTY-101 · Biological: IL-2 · Drug: Lymphodepleting Chemotherapy

Interventions

  • BiologicalCNTY-101

    CNTY-101 cells for intravenous (IV) infusion

  • BiologicalIL-2

    IL-2 subcutaneous (SC) injection

  • DrugLymphodepleting Chemotherapy

    LDC as prespecified in the protocol.

06

What researchers measure

Primary outcomes

  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) of CNTY-101 With/Without IL-2 (With or Without Optimized LDC)

    Time frame: Up to 3 months after the first CNTY-101 infusion

Secondary outcomes

  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

  7. Percentage of Participants With Total Improvement Score (TIS) ≥20, ≥40, and ≥60

    Time frame: Up to 1 year

  8. Mean TIS

    Time frame: Baseline up to 1 year

  9. Change From Baseline in Each Core Set Measures (CSM)

    Time frame: Baseline up to 1 year

  10. Change From Baseline in CSM Component of Manual Muscle Testing (MMT)-8 Score

    Time frame: Baseline up to 1 year

  11. Change From Baseline in CSM Component of Patient Global Assessment (PtGA)

    Time frame: Baseline up to 1 year

  12. Change From Baseline in CSM Component of Physician Global Assessment (PhGA)

    Time frame: Baseline up to 1 year

  13. Change From Baseline in CSM Component of Muscle Enzyme Levels

    Time frame: Baseline up to 1 year

  14. Change From Baseline in CSM Component of Health Assessment Questionnaire- Disability Index (HAQ-DI) Score

    Time frame: Baseline up to 1 year

  15. Change From Baseline in CSM Component of Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT)

    Time frame: Baseline up to 1 year

  16. For Participants With Interstitial Lung Disease (ILD): Time to Improvement in Forced Vital Capacity (FVC%) ≥10%

    Time frame: Up to 1 year

  17. For Participants With ILD: Percentage of Participants With Improvement in FVC% ≥10%

    Time frame: Up to 1 year

  18. For Participants with ILD: Change From Baseline in Percent FVC (%FVC)

    Time frame: Baseline up to 1 year

  19. For Participants With ILD: Change From Baseline in Percent Diffusion Capacity of The Lung for Carbon Monoxide (%DLCO)

    Time frame: Baseline up to 1 year

  20. For Participants With ILD: Time to Progression in Interstitial Lung Disease (ILD)

    Time frame: Up to 1 year

  21. For Participants With ILD: Percentage of Participants With Progression in ILD

    Time frame: Up to 1 year

  22. For Participants With ILD: Change in Participant Reported Dyspnea Over Time as Measured by University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ)

    Time frame: Up to 1 year

  23. Change in American College of Rheumatology Combined Response in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS) Scores

    Time frame: Up to 1 year

  24. Percentage of Responders as Measured by ACR-CRISS Score

    Time frame: Up to 1 year

  25. Change From Baseline in ACR-CRISS Scores

    Time frame: Baseline up to 1 year

  26. Change From Baseline in Fibrosing Skin Disease Based on Modified Rodnan Skin Score (mRSS)

    Time frame: Baseline up to 1 year

  27. Change From Baseline in Scleroderma Health Assessment Questionnaire (SHAQ)

    Time frame: Baseline up to 1 year

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Aug 2028, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2024
First posted
Feb 12, 2024
StartActual
Feb 6, 2025
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2028
Last update
Jan 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06255028
Lead sponsor
Century Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 12, 2024
Start date
Feb 6, 2025
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jan 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Century Therapeutics, Inc.

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