Descartes-08 for patients with Systemic Lupus Erythematosus
Study Title:
Descartes-08 for patients with Systemic Lupus Erythematosus
Sponsor Name:
Cartesian Therapeutics
Purpose of Study:
This study is being conducted to evaluate the safety, tolerability, and ability to manufacture Descartes-08, an investigational mRNA CAR-T cell therapy, in people living with moderate to severe systemic lupus erythematosus (SLE).
What does this study involve?
Screening Period:
Potential participants will first attend a Screening visit to determine eligibility. During this visit, individuals will be asked to review and sign an informed consent form. The study team will be available to answer any questions to ensure that participants are adequately informed before agreeing to take part in the study. Certain tests and procedures will be performed to confirm eligibility.
Cell Collection (Leukapheresis):
Once eligibility is confirmed, participants will undergo leukapheresis, a procedure used to collect specific immune cells (T cells) from the blood, which are necessary to manufacture the individualized Descartes-08 study treatment. This procedure typically lasts 4–5 hours and requires placement of an intravenous (IV) line, which will be removed after the procedure.
Study Treatment Period (approximately 6 weeks):
Approximately 2–3 weeks after leukapheresis, participants will begin the study treatment with Descartes-08 (mRNA CAR-T cell therapy), receiving one IV infusion per week for 6 consecutive weeks. Each infusion visit will last approximately 2–4 hours, including post-infusion monitoring. No lymphodepleting chemotherapy is required prior to receiving Descartes-08. All infusions will be administered in an outpatient setting.
Study Follow-Up Period:
Following completion of the 6 infusions, participants will attend several follow-up visits to monitor SLE symptoms and general health. These visits may include additional blood tests.
The entire study duration is approximately 12 months. Up to 30 participants will be enrolled.
You May Be Able to Participate If You:
- Are at least 18 years old
- Diagnosed with SLE at least 24 weeks before the Screening visit
- Continue to have active lupus symptoms despite receiving immunosuppressive treatment
You May Not Be Able to Participate If You Have:
- Active, severe lupus nephritis
- Severe central nervous system lupus
Other eligibility criteria may apply. The study team will review all eligibility requirements with you.
Study Type:
Interventional, Phase 2a Open-Label Study
Email: trials@cartesiantx.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.