Bispecific Antibodies for Lupus Nephritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new drugs for lupus nephritis (LN), a kidney condition caused by lupus. The main goal is to determine if these drugs, Vonsetamig and Odronextamab (bispecific antibodies), are safe and how they affect the body over time. Researchers aim to understand how the body processes these drugs and whether any side effects occur. Individuals with lupus nephritis that remains unresponsive to current treatments might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new drugs.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that odronextamab generally has manageable safety in patients with relapsed/refractory follicular lymphoma, a cancer affecting the immune system. While some side effects occurred, they were usually controllable. Less specific information is available about vonsetamig's safety for lupus nephritis, but researchers are investigating its potential to safely lower certain antibodies that could affect kidney transplants.
This study, in its early phase, primarily focuses on assessing the safety of these drugs for people with lupus nephritis. Early-phase trials typically indicate that the drugs have undergone lab and animal testing but have limited human testing. The main goal is to determine if people can safely take these drugs and identify potential side effects.12345Why are researchers excited about this trial's treatments?
Most treatments for lupus nephritis, like corticosteroids and immunosuppressants, aim to reduce inflammation and suppress the immune system. However, Odronextamab and Vonsetamig offer a fresh approach by utilizing bispecific antibodies. These drugs are designed to simultaneously engage two different targets, potentially leading to more precise immune modulation. This innovative mechanism could mean more effective and less toxic treatment options compared to current therapies. Researchers are excited because these treatments might offer better control of lupus nephritis with fewer side effects.
What evidence suggests that this trial's treatments could be effective for Lupus Nephritis?
Research has shown that odronextamab, one of the treatments tested in this trial, yields promising results for various conditions. In some studies, up to 82% of patients responded well, with many experiencing complete symptom relief. This suggests potential effectiveness for lupus nephritis (LN).
Vonsetamig, another treatment option in this trial, targets specific parts of the immune system. Although limited data exists on its use for lupus nephritis, it affects immune responses that are often overactive in lupus, which could be beneficial. Both treatments aim to address immune system issues, a key factor in lupus nephritis.24678Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with lupus nephritis (a kidney problem caused by lupus) whose disease has not improved or has come back after previous treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive experimental bispecific antibody therapy for Lupus Nephritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Odronextamab
- Vonsetamig
Trial Overview
The study is testing two experimental drugs, Odronextamab and Vonsetamig, given separately to see how safe they are and how well patients tolerate them. Different groups will receive different doses in a carefully monitored setting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
1.
ashpublications.org
ashpublications.org/bloodadvances/article/9/15/3955/536732/Outcomes-of-bispecific-antibody-therapy-after-CAROutcomes of bispecific antibody therapy after CAR T-cell ...
Overall response rate (ORR) was 43%, with a progression-free survival (PFS) of 2.8 months. Patients receiving BsAbs during early relapse (≤3 ...
Safety and efficacy of odronextamab in patients with ...
At 20.1 months' efficacy follow-up, objective response rate was 80.0% and complete response rate was 73.4%. Median duration of complete response was 25.1 months ...
3.
researchgate.net
researchgate.net/publication/401207621_Comparative_effectiveness_of_odronextamab_monotherapy_versus_real-world_systemic_therapies_in_RR_follicular_lymphomaComparative effectiveness of odronextamab monotherapy ...
Overall response and complete response rates were 80% and 60% in the mosunetuzumab cohort and 75% and 33% in the RWD cohort, odds ratios of 1.23 (95% CI, 0.52- ...
4.
investor.regeneron.com
investor.regeneron.com/news-releases/news-release-details/updated-odronextamab-data-relapsedrefractory-diffuse-large-b/Updated Odronextamab Data from Relapsed/Refractory ...
52% objective response rate (ORR), with 31% achieving a complete response (CR). Responses were observed across high-risk subgroups, including ...
Updated Data for Odronextamab Show Durable ...
After a median follow-up of 26.2 months, 141 patients with DLBCL were evaluable for safety and 127 were evaluable for efficacy. Results showed ...
6.
ctv.veeva.com
ctv.veeva.com/study/dose-escalation-study-with-bispecific-antibodies-in-adult-patients-with-lupus-nephritisDose Escalation Study With Bispecific Antibodies in Adult ...
This study is researching a particular group of experimental drugs administered for a short period in the treatment of patients with lupus nephritis (LN).
Dose Escalation Study With Bispecific Antibodies in Adult ...
This study is researching a particular group of experimental drugs administered for a short period in the treatment of patients with Lupus Nephritis (LN).
Therapeutic potential of CD20/CD3 bispecific antibodies in the ...
Additionally, Obinutuzumab is undergoing Phase III clinical trials for SLE and lupus nephritis (LN). Furthermore, the anti-CD19 antibody ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.