The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants with Refractory B cell-mediated Autoimmune Diseases

Phase 1

Not yet recruiting

• Conditions: systemic lupus erythematosus [SLE]/lupus nephritis [LN], idiopathic inflammatory myopathy [IIM], and diffuse cutaneous systemic sclerosis [DcSSc]
• Interventions: Biological: CNTY-101; Biological: IL-2; Drug: Lymphodepleting Chemotherapy

• Registration Number: 2024-518797-13-00
• Lead Sponsor: Century Therapeutics Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-04-16
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A: CNTY-101 in SLE Participants	IL-2	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.
Arm C: CNTY-101 in IIM Participants	IL-2	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.
Arm B: CNTY-101 in LN Participants	IL-2	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.
Arm A: CNTY-101 in SLE Participants	CNTY-101	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.
Arm B: CNTY-101 in LN Participants	CNTY-101	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.
Arm A: CNTY-101 in SLE Participants	Lymphodepleting Chemotherapy	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.
Arm C: CNTY-101 in IIM Participants	Lymphodepleting Chemotherapy	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.
Arm D: CNTY-101 in DcSSC Participants	CNTY-101	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.
Arm B: CNTY-101 in LN Participants	Lymphodepleting Chemotherapy	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.
Arm C: CNTY-101 in IIM Participants	CNTY-101	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.
Arm D: CNTY-101 in DcSSC Participants	IL-2	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.
Arm D: CNTY-101 in DcSSC Participants	Lymphodepleting Chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
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
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs	Up to 29 days

Secondary Outcome Measures

Name	Time	Method
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 Low Disease Activity by Lupus Low Disease Activity State (LLDAS)	Up to 1 year
Percentage of Participants in Remission as Measured by Definitions of Remission in SLE (DORIS) Remission	Up to 1 year
Percentage of Participants With Total Improvement Score (TIS) ≥20, ≥40, and ≥60	Up to 1 year
Mean TIS	Baseline up to 1 year
Change From Baseline in Each Core Set Measures (CSM)	Baseline up to 1 year
Change From Baseline in CSM Component of Manual Muscle Testing (MMT)-8 Score	Baseline up to 1 year
Change From Baseline in CSM Component of Patient Global Assessment (PtGA)	Baseline up to 1 year
Change From Baseline in CSM Component of Physician Global Assessment (PhGA)	Baseline up to 1 year
Change From Baseline in CSM Component of Muscle Enzyme Levels	Baseline up to 1 year
Change From Baseline in CSM Component of Health Assessment Questionnaire- Disability Index (HAQ-DI) Score	Baseline up to 1 year
Change From Baseline in CSM Component of Extramuscular Assessment by Myositis Disease Activity Assessment Tool (MDAAT)	Baseline up to 1 year
For Participants With Interstitial Lung Disease (ILD): Time to Improvement in Forced Vital Capacity (FVC%) ≥10%	Up to 1 year
For Participants With ILD: Percentage of Participants With Improvement in FVC% ≥10%	Up to 1 year
For Participants With ILD: Change From Baseline in Percent Diffusion Capacity of The Lung for Carbon Monoxide (%DLCO)	Baseline up to 1 year
For Participants With ILD: Time to Progression in Interstitial Lung Disease (ILD)	Up to 1 year
For Participants With ILD: Percentage of Participants With Progression in ILD	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)	Up to 1 year
Change in American College of Rheumatology Combined Response in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS) Scores	Up to 1 year
Change From Baseline in ACR-CRISS Scores	Baseline up to 1 year
Change From Baseline in Fibrosing Skin Disease Based on Modified Rodnan Skin Score (mRSS)	Baseline up to 1 year
Change From Baseline in Scleroderma Health Assessment Questionnaire (SHAQ)	Baseline 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
Percentage of Participants With SLE - Responder Index 4 (SRI-4) Response	Up to 1 year
For Participants with ILD: Change From Baseline in Percent FVC (%FVC)	Baseline up to 1 year
Percentage of Responders as Measured by ACR-CRISS Score	Up to 1 year

Trial Locations

Locations (5)

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Centre Hospitalier Universitaire De Toulouse; 🇫🇷 Toulouse Cedex 9, France

Les Hopitaux Universitaires De Strasbourg; 🇫🇷 Strasbourg Cedex 2, France

Johannes Wesling Klinikum Minden

🇩🇪Minden, Germany

Gunter Aßmann

Site contact

+495717903831

gunter.assmann@muehlenkreiskliniken.de