Rapcabtagene Autoleucel for Lupus Nephritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests rapcabtagene autoleucel, an anti-CD19 chimeric antigen receptor T cell therapy, to help people with lupus nephritis, a kidney condition caused by systemic lupus erythematosus (SLE). The trial aims to evaluate the treatment's effectiveness and safety for those who have not responded to at least two other therapies. Suitable candidates for this trial have active lupus nephritis, struggle to control their symptoms, and possess specific lupus-related antibodies in their blood. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial mentions an 'immunosuppressive washout' period, which suggests you may need to stop taking certain medications that suppress the immune system before participating. However, the protocol does not specify which medications or how long the washout period is.
Is there any evidence suggesting that rapcabtagene autoleucel is likely to be safe for humans?
Research has shown that rapcabtagene autoleucel, a new type of CAR-T cell therapy, shows promise in studies. Early results suggest it is well-tolerated by patients with systemic lupus erythematosus (SLE), a long-term autoimmune disease. Administered once after a procedure called lymphodepletion, this therapy prepares the body for treatment.
While researchers continue to gather information about its effects on lupus nephritis (a kidney problem related to SLE), the overall safety profile of rapcabtagene autoleucel appears positive. Any side effects reported so far have been manageable. As the treatment undergoes further testing, researchers are closely monitoring for any unexpected issues. However, the results so far are encouraging for those considering joining a trial.12345Why do researchers think this study treatment might be promising for lupus nephritis?
Unlike the standard treatments for lupus nephritis, which usually involve immunosuppressive drugs and steroids, rapcabtagene autoleucel is an innovative approach that uses a patient's own immune cells to fight the disease. This treatment is a form of CAR-T cell therapy, where T cells are engineered to specifically target and attack the cells causing harm in lupus nephritis. Researchers are excited about this therapy because it has the potential to provide long-lasting remission by addressing the root cause of the condition, rather than just managing symptoms. This could mean fewer side effects and a more sustainable treatment option for patients.
What evidence suggests that rapcabtagene autoleucel might be an effective treatment for lupus nephritis?
Research has shown that rapcabtagene autoleucel, the treatment under study in this trial, may hold promise for treating lupus nephritis. Early data suggest it is safe and effective in increasing CAR T-cells, which help reduce B-cells involved in lupus. These initial findings indicate it might work well for managing severe, hard-to-treat cases of systemic lupus erythematosus, closely linked to lupus nephritis. Although more research is needed, these results offer hope for those seeking new treatment options.12345
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for people with active, hard-to-treat lupus nephritis—a kidney condition caused by systemic lupus erythematosus. Participants should have tried other treatments without success. Specific criteria for joining or reasons to be excluded aren't provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either rapcabtagene autoleucel or Standard of Care (SOC) for systemic lupus erythematosus with active, refractory lupus nephritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up period
What Are the Treatments Tested in This Trial?
Interventions
- Rapcabtagene Autoleucel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD