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CNTY-101

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |Century Therapeutics, Inc.|Last Updated: Jan 8, 2026

Success Probability
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical trial landscape

CNTY-101 · 1 trial · 4 indications

Phase 1 1
NCT06255028A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune DiseasesSystemic Lupus Erythematosus
ACTIVE NOT_RECRUITING6 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
Systemic Lupus ErythematosusUnlock trial analytics
Study Endpoints
Primary Endpoints
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Up to 29 days
Percentage of Participants With Dose Limiting Toxicities (DLTs)
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)
Up to 3 months after the first CNTY-101 infusion
Secondary Endpoints
Percentage of Participants With TEAEs and Serious Adverse Events (SAEs)
Day 1 up to 1 year
Percentage of Participants With Clinically Significant Laboratory Abnormalities and Severity of Laboratory Abnormalities
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
Day 1 up to 1 year
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: CNTY-101 in SLE ParticipantsEXPERIMENTALDuring 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 ParticipantsEXPERIMENTALDuring 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 ParticipantsEXPERIMENTALDuring 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 ParticipantsEXPERIMENTALDuring 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.
Interventions
NameTypeDescription
CNTY-101BIOLOGICALCNTY-101 cells for intravenous (IV) infusion
IL-2BIOLOGICALIL-2 subcutaneous (SC) injection
Lymphodepleting ChemotherapyDRUGLDC as prespecified in the protocol.
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Eligibility Criteria
Age Range17 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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/Am...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06255028primaryCompletionDate: changed
LOWMay 24, 2026NCT06255028studyFirstPostDate: changed