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CNTY-101

Phase 1

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

Target and mechanism

Molecular targetCD19
Target classAntigen
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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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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Frequently asked questions about CNTY-101

What is CNTY-101 used for in Systemic Lupus Erythematosus?

CNTY-101 is an investigational monoclonal antibody being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and is being studied in patients with refractory B cell-mediated autoimmune diseases, including SLE and lupus nephritis.

What does CNTY-101 target?

CNTY-101 targets CD19, an antigen expressed on B cells. By targeting CD19, the drug is designed to modulate B cell activity, which is relevant to autoimmune conditions like Systemic Lupus Erythematosus where B cells play a pathogenic role.

Who makes CNTY-101?

CNTY-101 is being developed by Century Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IPSC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in autoimmune diseases.

What phase is CNTY-101 in?

CNTY-101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling participants to assess the drug in refractory B cell-mediated autoimmune diseases.

What clinical trials is CNTY-101 in?

CNTY-101 is being evaluated in a Phase 1 clinical trial registered as NCT06255028, titled "A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases." The trial is active but not recruiting, with an enrollment of 6 participants, and is being conducted in the United States.

Is CNTY-101 the same as any other drug?

No alternative names for CNTY-101 have been reported. It is a distinct investigational monoclonal antibody developed by Century Therapeutics, Inc., and is not known to be marketed under any other name.