ACTIVE_NOT_RECRUITING

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

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Conditions

Systemic Lupus ErythematosusLupus NephritisIdiopathic Inflammatory MyopathiesDiffuse Cutaneous Systemic SclerosisCAR iNKCAR NKCellular therapySLEInduced pluripotent stem cell (iPSC)Anti-CD19 therapyCNTY-101Autoimmune diseaseLupusIIMDcSScMyositisPolymyositisDermatomyositisAnti-synthetase syndromeSystemic sclerosisSclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-02-06
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06255028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Keck School of Medicine of University of Southern California
Los Angeles, California, 90033
United States
UC Davis
Sacramento, California, 957817
United States
Lurie Children's; Northwestern Medicine - Northwestern Medical Group
Chicago, Illinois, 60611
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Fred Hutch
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Century Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • CAR iNK
  • CAR NK
  • Cellular therapy
  • Systemic Lupus Erythematosus
  • SLE
  • Induced pluripotent stem cell (iPSC)
  • Anti-CD19 therapy
  • CNTY-101
  • Autoimmune disease
  • Lupus Nephritis
  • Lupus
  • Idiopathic Inflammatory Myopathies
  • Diffuse Cutaneous Systemic Sclerosis
  • IIM
  • DcSSc
  • Myositis
  • Polymyositis
  • Dermatomyositis
  • Anti-synthetase syndrome
  • Systemic sclerosis
  • Sclerosis

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Lupus Nephritis
  • Idiopathic Inflammatory Myopathies
  • Diffuse Cutaneous Systemic Sclerosis