CALiPSO-1
Study Title:
A Study of CNTY-101 in Participants with Refractory B Cell-mediated Autoimmune Diseases (CALiPSO-1)
Sponsor Name:
Century Therapeutics. Inc.
Purpose of Study:
The purpose of this study is to evaluate the safety and efficacy of CNTY-101, an investigational “off-the-shelf” CD19 Chimeric Antigen Receptor (CAR) Natural Killer (NK)-cell therapy, in participants with refractory B cell-mediated autoimmune diseases, including those with moderate to severe systemic lupus erythematosus (SLE) and lupus nephritis (LN, lupus-related kidney disease). An “off-the-shelf” cell therapy means that treatment is prepared in advance and is ready whenever a patient needs it.
What does this study involve?
Approximately 12 people living with SLE and 12 people living with LN will be enrolled in this cell therapy study.
- Participants will undergo screening procedures to determine eligibility, including assessments of organ function and disease activity.
- Some ongoing medications will need to be decreased or stopped prior to receiving chemotherapy.
- Prior to receiving the first dose, participants will undergo a short chemotherapy treatment, which helps reduce the white blood cells that could obstruct CNTY-101 investigational CAR NK-cell therapy.
- Eligible participants will receive up to six doses of CNTY-101 over two months.
- Participants will be monitored closely for safety and response to treatment for up to a year.
- Participants will be invited to participate in the long-term follow-up study lasting for 15 years.
You May Qualify for This Study if You:
- Are at least 17 years of age
- Have a diagnosis of SLE and/or LN
- Have active disease that has not responded to at least 2 therapies used to treat lupus as part of standard care practices
If You Have Any of the Following, You May Not Be Able to Participate in the Study:
- Are currently on hemodialysis
- Have other autoimmune diseases (e.g., multiple sclerosis, systemic sclerosis, inflammatory bowel disease, etc.)
Participants with type I autoimmune diabetes mellitus, autoimmune thyroid disease, celiac disease, anti-phospholipid syndrome, mixed connective tissue disease, or overlap syndrome may participate.
Study Type:
- Interventional
- Phase 1 multicenter
- USA and Europe study
Eligible patients may receive support to help with any or all following items:
- Pre-paid travel assistance for flights, car services, or mileage reimbursement
- Accommodations and meals for both participant and companion
Email: trial_response_century@centurytx.com
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.