Evaluating the safety of vonsetamig for kidney transplant patients with high HLA sensitization
A Dose Escalation and Proof-of-Concept Study of Vonsetamig (BCMA × CD3 Bispecific Antibody) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen
This study is testing if vonsetamig is safe and helps kidney transplant patients who have high levels of antibodies that make it hard to find a donor.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | rituximab, obinutuzumab, isatuximab, daratumumab, CAR-T, cyclophosphamide, prednisone |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT05092347 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of vonsetamig in adult patients with chronic kidney disease (CKD) who are highly sensitized to human leukocyte antigen (HLA) and require kidney transplantation. The research will evaluate the drug's effectiveness in reducing anti-HLA antibodies, which can hinder successful transplantation. Additionally, the study will monitor potential side effects, the pharmacokinetics of vonsetamig, and its overall impact on antibody levels. Participants will be closely monitored throughout the trial to ensure compliance and safety.
Who should consider this trial
Good fit: Ideal candidates are adults with CKD requiring hemodialysis, who are on the transplant waiting list and have a calculated panel reactive antibody (cPRA) of 98% or higher.
Not a fit: Patients with active malignancies, certain neurological disorders, or those who have had their spleen removed may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the chances of kidney transplantation for highly sensitized patients.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting desensitization in kidney transplantation have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol 2. Adequate hematologic and adequate hepatic function as defined in the protocol 3. Willing and able to comply with clinic visits and study-related procedures Key Exclusion Criteria: 1. Current or active malignancy not in remission for at least 1 year 2. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders 3. Patients who have had their spleen removed, including patients with functional asplenia 4. Patients who have received a stem cell transplantation within 5 years 5. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger) 6. Total plasma IgG \<300 mg/dL at screening 7. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration 8. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration 9. Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration 10. Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy, as described in the protocol 11. Has received a COVID-19 vaccination, as described in the protocol Note: Other protocol defined inclusion / exclusion criteria apply
Where this trial is running
Los Angeles, California and 9 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California Irvine — Orange, California, United States (Recruiting)
- Connie Frank Transplant Center at UCSF — San Francisco, California, United States (Recruiting)
- Yale University of Medicine — New Haven, Connecticut, United States (Recruiting)
- Medstar Georgetown Transplant Institute - 2-PHC — Washington D.C., District of Columbia, United States (Recruiting)
- Comprehensive Transplant Center — Chicago, Illinois, United States (Recruiting)
- John Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- New York University Langone Health — New York, New York, United States (Recruiting)
- Penn Transplant Institute — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.