R5459-RT-1944: Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Ki
UCI Specialty Area: Nephrology
Principal Investigator:
Robert Redfield III
Official Title:
A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMA × CD3 Bispecific Antibodies) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen
A Study On:
Kidney - Nephrology
Study Description
Eligibility
- 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
- Adequate hematologic and adequate hepatic function as defined in the protocol
- Willing and able to comply with clinic visits and study-related procedures
Key
- Current or active malignancy not in remission for at least 1 year
- Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
- Patients who have had their spleen removed, including patients with functional asplenia
- Patients who have received a stem cell transplantation within 5 years
- Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
- Hypogammaglobulinemia, defined as total plasma IgG <300 mg/dL at screening
- 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
- Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
- Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 6 months of study drug administration
- Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy
- Has received a COVID-19 vaccination within 1 week of planned start of study drug, or for which the planned COVID-19 vaccination would not be completed 1 week before start of study drug
Note: Other protocol defined inclusion / exclusion criteria apply
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.