Systemic Lupus ErythematosusPhase 1CALiPSO-1NCT06255028
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
A Phase 1 study testing CNTY-101, IL-2 and Lymphodepleting Chemotherapy in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Century Therapeutics, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies
- What is being tested?
- CNTY-101, IL-2 and Lymphodepleting Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Feb 2025to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- 17 years of age and older.
- Participants must have adequate organ function as defined in the protocol.
- SLE/LN-specific Inclusion Criteria:
- 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.
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- SLE-specific Inclusion Criteria:
- 1. Participants who have:
- 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.
- LN-specific Inclusion Criteria:
- 1. Participants with active, biopsy-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):
- 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.
- 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:
- 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:
- Meets the 2013 ACR/EULAR criteria for SSc with a total score of ≥9.
- Meets criteria for DcSSc, including skin involvement proximal to the elbow and/or knee.
- mRSS units ≥15 at Screening; for participants agreeing to biopsy, skin thickening from SSc in the forearm suitable for biopsy.
Who cannot join
- General Exclusion Criteria:
- Participants on hemodialysis.
- 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.
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- Participants with severe hepatic dysfunction, defined as grade C-Child-Pugh.
- SLE-specific Exclusion Criteria:
- Participants with BILAG A for neuropsychiatric SLE.
- Any current, acute, and severe lupus-related flare that needs immediate treatment.
- Drug-induced SLE rather than idiopathic SLE.
- 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.
- Participants with estimated glomerular filtration rate (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:
- Participants with BILAG A for neuropsychiatric SLE.
- 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.
- Drug-induced SLE rather than idiopathic SLE.
- Participants with predominantly LN Class V, or Class VI on the most recent biopsy according to the 2018 revised ISN/RPS criteria.
- 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:
- 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.
- Have severe muscle damage as defined in the protocol.
- Participants with ILD will be excluded if there is severe end stage lung disease as defined in the protocol.
- DcSSc-specific Exclusion Criteria
- 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.
- Participants with ILD will be excluded if there is severe end stage lung disease as defined in the protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lurie Children's; Northwestern Medicine - Northwestern Medical Group
Chicago, Illinois, 60611
Texas Children's Hospital
Houston, Texas, 77030
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033
UC Davis
Sacramento, California, 957817
Primary Children's Hospital
Salt Lake City, Utah, 84113
Fred Hutch
Seattle, Washington, 98109
About this study
Official title: 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
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).
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Being tested
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- 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
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Myositis, Scleroderma, Diffuse, Autoimmune Diseases, Polymyositis, Dermatomyositis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTY-101Biological
CNTY-101 cells for intravenous (IV) infusion
IL-2Biological
IL-2 subcutaneous (SC) injection
Lymphodepleting ChemotherapyDrug
LDC as prespecified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: CNTY-101 in SLE Participants | Experimental | 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. Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy |
| Arm B: CNTY-101 in LN Participants | Experimental | 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. Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy |
| Arm C: CNTY-101 in IIM Participants | Experimental | 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. Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy |
| Arm D: CNTY-101 in DcSSC Participants | Experimental | 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. Receives: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Measured: Up to 29 days
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Measured: Up to 28 days after first CNTY-101 infusion
Recommended Phase 2 Regimen (RP2R) of CNTY-101 With/Without IL-2 (With or Without Optimized LDC)
Measured: Up to 3 months after the first CNTY-101 infusion
Secondary outcomes (27)
Percentage of Participants With TEAEs and Serious Adverse Events (SAEs)
Measured: Day 1 up to 1 year
Percentage of Participants With Clinically Significant Laboratory Abnormalities and Severity of Laboratory Abnormalities
Measured: Day 1 up to 1 year
Percentage of Participants With Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Severity of CRS and ICANS
Measured: Day 1 up to 1 year
Percentage of Participants With SLE - Responder Index 4 (SRI-4) Response
Measured: Up to 1 year
Percentage of Participants With Low Disease Activity by Lupus Low Disease Activity State (LLDAS)
Measured: Up to 1 year
Percentage of Participants in Remission as Measured by Definitions of Remission in SLE (DORIS) Remission
Measured: Up to 1 year
Percentage of Participants With Total Improvement Score (TIS) ≥20, ≥40, and ≥60
Measured: Up to 1 year
Mean TIS
Measured: Baseline up to 1 year
Change From Baseline in Each Core Set Measures (CSM)
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Manual Muscle Testing (MMT)-8 Score
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Patient Global Assessment (PtGA)
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Physician Global Assessment (PhGA)
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Muscle Enzyme Levels
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
Measured: Baseline up to 1 year
Change From Baseline in CSM Component of Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT)
Measured: Baseline up to 1 year
For Participants With Interstitial Lung Disease (ILD): Time to Improvement in Forced Vital Capacity (FVC%) ≥10%
Measured: Up to 1 year
For Participants With ILD: Percentage of Participants With Improvement in FVC% ≥10%
Measured: Up to 1 year
For Participants with ILD: Change From Baseline in Percent FVC (%FVC)
Measured: Baseline up to 1 year
For Participants With ILD: Change From Baseline in Percent Diffusion Capacity of The Lung for Carbon Monoxide (%DLCO)
Measured: Baseline up to 1 year
For Participants With ILD: Time to Progression in Interstitial Lung Disease (ILD)
Measured: Up to 1 year
For Participants With ILD: Percentage of Participants With Progression in ILD
Measured: Up to 1 year
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)
Measured: Up to 1 year
Change in American College of Rheumatology Combined Response in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS) Scores
Measured: Up to 1 year
Percentage of Responders as Measured by ACR-CRISS Score
Measured: Up to 1 year
Change From Baseline in ACR-CRISS Scores
Measured: Baseline up to 1 year
Change From Baseline in Fibrosing Skin Disease Based on Modified Rodnan Skin Score (mRSS)
Measured: Baseline up to 1 year
Change From Baseline in Scleroderma Health Assessment Questionnaire (SHAQ)
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start6 Feb 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Century Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255028
- Sponsor's protocol ID
- CNTY-101-151-01
- Other IDs
- 2024-518797-13
- Acronym
- CALiPSO-1
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06255028
- Acronym / sponsor ID
- CALiPSO-1 / CNTY-101-151-01
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Century Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: CNTY-101 in SLE Participants | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyDuring 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. |
| Arm B: CNTY-101 in LN Participants | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyDuring 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. |
| Arm C: CNTY-101 in IIM Participants | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyDuring 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. |
| Arm D: CNTY-101 in DcSSC Participants | Experimental | Biological: CNTY-101, Biological: IL-2, Drug: Lymphodepleting ChemotherapyDuring 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (26 listed)
- Participants on hemodialysis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTY-101CNTY-101 cells for intravenous (IV) infusion | Biological | Arm A: CNTY-101 in SLE Participants, Arm B: CNTY-101 in LN Participants, Arm C: CNTY-101 in IIM Participants, Arm D: CNTY-101 in DcSSC Participants |
| IL-2IL-2 subcutaneous (SC) injection | Biological | Arm A: CNTY-101 in SLE Participants, Arm B: CNTY-101 in LN Participants, Arm C: CNTY-101 in IIM Participants, Arm D: CNTY-101 in DcSSC Participants |
| Lymphodepleting ChemotherapyLDC as prespecified in the protocol. | Drug | Arm A: CNTY-101 in SLE Participants, Arm B: CNTY-101 in LN Participants, Arm C: CNTY-101 in IIM Participants, Arm D: CNTY-101 in DcSSC Participants |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Time frame: Up to 29 days
Percentage of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days after first CNTY-101 infusion
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
27 secondary outcomes
Percentage of Participants With TEAEs and Serious Adverse Events (SAEs)
Time frame: Day 1 up to 1 year
Percentage of Participants With Clinically Significant Laboratory Abnormalities and Severity of Laboratory Abnormalities
Time frame: Day 1 up to 1 year
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
Percentage of Participants With SLE - Responder Index 4 (SRI-4) Response
Time frame: Up to 1 year
Percentage of Participants With Low Disease Activity by Lupus Low Disease Activity State (LLDAS)
Time frame: Up to 1 year
Percentage of Participants in Remission as Measured by Definitions of Remission in SLE (DORIS) Remission
Time frame: Up to 1 year
Percentage of Participants With Total Improvement Score (TIS) ≥20, ≥40, and ≥60
Time frame: Up to 1 year
Mean TIS
Time frame: Baseline up to 1 year
Change From Baseline in Each Core Set Measures (CSM)
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Manual Muscle Testing (MMT)-8 Score
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Patient Global Assessment (PtGA)
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Physician Global Assessment (PhGA)
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Muscle Enzyme Levels
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Health Assessment Questionnaire- Disability Index (HAQ-DI) Score
Time frame: Baseline up to 1 year
Change From Baseline in CSM Component of Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT)
Time frame: Baseline up to 1 year
For Participants With Interstitial Lung Disease (ILD): Time to Improvement in Forced Vital Capacity (FVC%) ≥10%
Time frame: Up to 1 year
For Participants With ILD: Percentage of Participants With Improvement in FVC% ≥10%
Time frame: Up to 1 year
For Participants with ILD: Change From Baseline in Percent FVC (%FVC)
Time frame: Baseline up to 1 year
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
For Participants With ILD: Time to Progression in Interstitial Lung Disease (ILD)
Time frame: Up to 1 year
For Participants With ILD: Percentage of Participants With Progression in ILD
Time frame: Up to 1 year
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
Change in American College of Rheumatology Combined Response in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS) Scores
Time frame: Up to 1 year
Percentage of Responders as Measured by ACR-CRISS Score
Time frame: Up to 1 year
Change From Baseline in ACR-CRISS Scores
Time frame: Baseline up to 1 year
Change From Baseline in Fibrosing Skin Disease Based on Modified Rodnan Skin Score (mRSS)
Time frame: Baseline up to 1 year
Change From Baseline in Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Baseline up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTY-101, IL-2 and Lymphodepleting Chemotherapy in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Century Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs (time frame: Up to 29 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.