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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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
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
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
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