Daratumumab and Belatacept for Desensitization

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

March 31, 2027

Study Completion Date

April 30, 2028

Conditions
Highly Sensitized Prospective Kidney Transplant Recipients
Interventions
BIOLOGICAL

daratumumab

"Daratumumab is a CD38 (Cluster of Differentiation 38)-directed cytolytic monoclonal antibody indicated for the treatment of multiple myeloma. In this study, daratumumab will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.~Definition of highly sensitized: Potential kidney transplant recipients with either:~* calculated panel reactive antibodies (cPRA) ≥99.9% awaiting deceased donor transplant, or~* cPRA \>98% (with \>5 years of waiting time) awaiting living donor transplant"

BIOLOGICAL

belatacept

Belatacept, a monoclonal antibody, is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in subjects who have not received a kidney transplant.

PROCEDURE

Bone marrow aspiration

Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 12 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been \>4 weeks since the previous bone marrow aspiration.

Trial Locations (1)

94143

RECRUITING

University of California at San Francisco Medical Center, San Francisco

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH