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New treatment option for Lupus Erythematosus, Systemic
Official title A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
ClinicalTrials.gov ID: NCT07015983
What this study is testing
What is CC-97540?
CC-97540 is an investigational medicine, being studied as a potential treatment for lupus erythematosus, systemic.
Also referred to as BMS-986353, Zola-cel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Participants must meet EULAR/ACR 2019 criteria for SLE.
- Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
- Participants must have active disease when signing ICF.
You likely can't join if
- Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
- Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or...
- IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
- Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.
- Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
- Participant must not have inadequate organ function.
See the full eligibility criteria
- Participants must meet EULAR/ACR 2019 criteria for SLE.
- Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
- Participants must have active disease when signing ICF.
- Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
- Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the...
- IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
- Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.
- Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
- Participant must not have inadequate organ function.
- Other protocol-defined inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Zephyrhills, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Baton Rouge, Louisiana, United States
- Shreveport, Louisiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Summit, New Jersey, United States
- Manhasset, New York, United States
+ 61 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.