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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 17 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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, 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): 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:

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 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. 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 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). 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06255028
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Century Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
Arms & Interventions

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.

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.

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.

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.

Interventions

Biological: - CNTY-101

CNTY-101 cells for intravenous (IV) infusion

Biological: - IL-2

IL-2 subcutaneous (SC) injection

Drug: - Lymphodepleting Chemotherapy

LDC as prespecified in the protocol.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

Keck School of Medicine of University of Southern California

Los Angeles, California, 90033

Site Contact

Sara Madrigal

[email protected]

323-409-4349

UC Davis, Sacramento, California

Status

Recruiting

Address

UC Davis

Sacramento, California, 957817

Site Contact

Elizabeth Robison

[email protected]

916-734-8101

Chicago, Illinois

Status

Recruiting

Address

Lurie Children's; Northwestern Medicine - Northwestern Medical Group

Chicago, Illinois, 60611

Site Contact

Eric Brown

[email protected]

312-227-4871

Texas Children's Hospital, Houston, Texas

Status

Recruiting

Address

Texas Children's Hospital

Houston, Texas, 77030

Site Contact

David Allen

[email protected]

832-824-4391

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Site Contact

Michelle Wilcox

[email protected]

801-581-6410