A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
NCT ID: NCT06255028
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
6 participants
INTERVENTIONAL
2025-02-06
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SC) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
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.
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SC) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
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.
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SC) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
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.
CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SC) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Interventions
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CNTY-101
CNTY-101 cells for intravenous (IV) infusion
IL-2
IL-2 subcutaneous (SC) injection
Lymphodepleting Chemotherapy
LDC as prespecified in the protocol.
Eligibility Criteria
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Inclusion Criteria
2. Participants must have adequate organ function as defined in the protocol.
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.
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.
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.
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
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
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 autologous stem cell transplant \>100 days prior to Screening is allowed.
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. Thromboembolic events within last 12 months.
6. Participants with severe hepatic dysfunction, defined as grade C-Child-Pugh.
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 biopsy according to the 2018 revised ISN/RPS criteria.
5. 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).
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.
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.
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.
17 Years
ALL
No
Sponsors
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Century Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Keck School of Medicine of University of Southern California
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
Lurie Children's; Northwestern Medicine - Northwestern Medical Group
Chicago, Illinois, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Fred Hutch
Seattle, Washington, United States
Countries
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Other Identifiers
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2024-518797-13
Identifier Type: OTHER
Identifier Source: secondary_id
CNTY-101-151-01
Identifier Type: -
Identifier Source: org_study_id
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