CALIPSO-1: LET’S WORK TO ADVANCE THE CARE FOR AUTOIMMUNE DISEASES
What is the CALiPSO-1 Clinical Trial?
CALIPSO-1 is a Phase I clinical trial to evaluate a potential new treatment for Refractory B Cell-Mediated Autoimmune Diseases. The study will assess the safety and effects of CNTY-101, a type of cell therapy designed to target B cells, which play a role in diseases such as:
➡️ Systemic Lupus Erythematosus (SLE)
➡️ Lupus Nephritis (LN)
➡️ Idiopathic Inflammatory Myopathy (IIM)
➡️ Diffuse Cutaneous Systemic Sclerosis (DcSSc)
CNTY-101 uses cells from a healthy donor that are modified with genetic edits and cryopreserved, a.k.a. “off-the-shelf” cell therapy, to treat autoimmune diseases. This cell therapy is considered investigational since it has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of clinical studies, including for these conditions.
Therapies like CNTY-101 can potentially overcome many of the challenges of currently available treatment for autoimmunity. If you and your doctor determine that CNTY-101 is the right option for you and you meet the eligibility criteria, you may have the opportunity to participate in the study. As part of the trial, you could receive study-related care at no cost, which may include travel, meals and accommodations.
What to Expect in the Study
The trial consists of up to two treatment cycles over approximately two months, followed by a monitoring period of up to one year.
Step-by-Step Process
➡️ Consent & Screening: Written consent and eligibility assessments before treatment.
➡️ Lymphodepletion: Three-day treatment with chemotherapy agents to prepare the immune system.
➡️ CNTY-101 Infusions: Three or six doses of CNTY-101 over one or two cycles.
➡️ Inpatient Monitoring: A short hospital stay of three days after the first dose.
➡️ Follow-Up: Stay within one hour of the trial site for approximately 60 days, with follow-ups for up to one year.
For more information, please reach out to: trial_response_century@centurytx.com
TAKING PART IS VOLUNTARY
You do not need to take part in any clinical trial if you don’t want to. Even if you qualify and decide to join, you are free to leave at any time.
What Support is Provided?
Explore Your Eligibility
The trial is currently recruiting or preparing to recruit at the following locations:
Los Angeles, CA – Keck School of Medicine of University of Southern California (Recruiting)
➡️ Contact: Sara Madrigal – smadriga@usc.edu | 📞 323-409-4349
Sacramento, CA – UC Davis (Not Yet Recruiting)
➡️ Contact: Elizabeth Robison – eerobison@ucdavis.edu | 📞 916-734-8101
Chicago, IL – Lurie Children’s / Northwestern Medicine – Northwestern Medical Group (Recruiting)
➡️ Contact: Eric Brown – errbrown@luriechildrens.org | 📞 312-227-4871
Houston, TX – Texas Children’s Hospital (Recruiting)
➡️ Contact: David Allen – dlallen@texaschildrens.org | 📞 832-824-4391
Salt Lake City, UT – Primary Children’s Hospital (Recruiting)
➡️ Contact: Michelle Wilcox – michelle.o.wilcox@hsc.utah.edu | 📞 801-581-6410
Take the Next Step
Key Eligibility & Participation
Who can participate?
To qualify, you must:
✔️ Be 17 years or older
✔️ Have moderate to severe SLE, LN, IIM, or DcSSc
✔️ Have previously tried at least two standard immunosuppressive therapies that did not work
Who is NOT eligible?
You may not be eligible if you:
❌ Are currently on hemodialysis
❌ Take certain medications that need to be decreased or stopped.
❌ Have other health conditions that may make you ineligible.
Ask your doctor for details.
Additional eligibility criteria apply.