CLN-978
Study Title:
A Phase 1b, Open-label, Pilot Study of CLN-978 Subcutaneously Administered for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Sponsor Name:
Cullinan Therapeutics
Purpose of Study:
The study is evaluating an investigational drug, CLN-978, which falls in the category of a T Cell Engager, in people with moderate to severe SLE. T cell engagers work by guiding the body’s own T cells, a type of immune cell, to recognize and eliminate certain cells in the body. CLN-978 directs T cells to kill the body’s B cells, which are important drivers of lupus disease activity.
The purpose of the study is to assess the safety, potential effectiveness, and effects of the drug on biologic markers of CLN-978 in people who have active SLE and have not responded well to at least two previous treatments, with one of the two being a biologic therapy (a type of therapy that uses substances derived from living organisms to fight disease) or cyclophosphamide.
What does this study involve?
About 36 individuals will be enrolled in this study. Participation will last about one year with an optional second year of follow-up and consist of the following periods:
- Screening period (up to 4 weeks): During this time, you will have a screening visit where the study team will perform certain procedures to determine if you are eligible for the study, like blood/urine collection, an electrocardiogram (ECG), and a physical exam.
- Study treatment period (next 4 weeks): If eligible, you will receive an injection of CLN-978 subcutaneously (under your skin) and then stay for 48 hours in a hospital or other specialized facility. The injection will be done on Day 1 of the treatment period and participants may receive up to 4 weekly injections in total. Since this is an open-label study, all participants will receive active study medication.
- Follow-up period: You will then have 8 follow-up study visits over the course of the next 48 weeks). These visits are to check on your health and will include blood and urine tests, electrocardiograms (ECGs), physical exams, and assessments to evaluate your SLE disease activity.
- Long-term follow-up period: If you complete the follow-up period that is listed above, you have the option to stay in the study for an additional year. This would include study visits approximately every 3 months.
To Consider Participation in This Study, You Must:
- Be between 18 to 70 years old
- Be diagnosed with SLE at least 6 months prior to starting the study and have active SLE symptoms
- Have tested positive for certain lupus-related antibodies
- Have NOT responded well to at least two previous lupus treatments, with one of those 2 treatments being a biologic therapy (such as belimumab, anifrolumab, or rituximab) or cyclophosphamide
If you have any of the following, you will not be able to participate:
- Another active inflammatory disease (however having thyroiditis and/or Sjogren’s diseaes is allowed)
- Kidney disease that requires urgent treatment, or certain types of severe nerve or brain involvement from SLE
- Evidence of hepatitis B or C infection, HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infections
- Had your spleen removed
- Received gene or cell therapy
- Active or untreated tuberculosis (TB)
There are additional eligibility requirements which the study team will discuss with you. If you don’t qualify now, you may choose to be contacted later to see if you qualify in the future.
The study team can review all eligibility criteria with you, and let you know if you may qualify.
Study Type:
- Phase 1, open label, multicenter
- Interventional
The investigational drug has not yet been approved by any regulatory agency responsible for approving new medicines. There may be risks associated with participating in this study, and the study team will discuss these with you. The investigational drug, study-related laboratory tests, examinations, and clinic visits will be provided to you at no cost. You may also be reimbursed for travel expenses incurred while attending study visits.
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.