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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Healthy Volunteers: f
View:

• 17 years of age and older.

• Participants must have adequate organ function as defined in the protocol.

⁃ SLE/LN-specific Inclusion Criteria:

• 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.

• 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:

• 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

• 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):

• For Dermatomyositis (DM), meet 2017 American College of Rheumatology/European Alliance of Associations of Rheumatology (ACR/EULAR) diagnostic criteria for definite or probable DM.

• 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.

• 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:

• Meets the 2013 ACR/EULAR criteria for SSc with a total score of ≥9.

• Meets criteria for DcSSc, including skin involvement proximal to the elbow and/or knee.

• mRSS units ≥15 at Screening; for participants agreeing to biopsy, skin thickening from SSc in the forearm suitable for biopsy.

Locations
United States
California
Keck School of Medicine of University of Southern California
RECRUITING
Los Angeles
UC Davis
RECRUITING
Sacramento
Illinois
Lurie Children's; Northwestern Medicine - Northwestern Medical Group
RECRUITING
Chicago
Texas
Texas Children's Hospital
RECRUITING
Houston
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Washington
Fred Hutch
RECRUITING
Seattle
Contact Information
Primary
Century Therapeutics Clinical Team
trial_response_century@centurytx.com
8885067670
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2028-08
Participants
Target number of participants: 48
Treatments
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.
Sponsors
Leads: Century Therapeutics, Inc.

This content was sourced from clinicaltrials.gov