CAR-T Cell Therapy for Desensitization in Kidney Transplantation

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 9, 2024

Primary Completion Date

December 15, 2028

Study Completion Date

December 15, 2042

Conditions
Kidney TransplantKidney FailureEnd Stage Renal Failure on Dialysis
Interventions
DRUG

Cyclophosphamide

"* Safety Run-in: 375mg/m\^2 daily x 3~* Cohort 1: 375mg/m\^2 daily x 3~* Cohort 2: 375mg/m\^2 daily x 3~* Cohort 3: 375mg/m\^2 daily x 3"

BIOLOGICAL

CART-BCMA

"* Safety Run-in: 5 x 10\^7 CAR T cells~* Cohort 1: 1.5 x 10\^8 CAR T cells~* Cohort 2: 1.5 x 10\^8 CAR T cells~* Cohort 3: 5 x 10\^8 CAR T cells"

BIOLOGICAL

huCART19

"* Safety Run-in: 5 x 10\^7 CAR T cells~* Cohort 1: 1.5 x 10\^8 CAR T cells~* Cohort 2: 1.5 x 10\^8 CAR T cells~* Cohort 3: 5 x 10\^8 CAR T cells"

DRUG

Fludarabine

• Cohort 3: 24mg/m\^2 daily x 3

Trial Locations (3)

10016

RECRUITING

NYU Langone Health (Site #: 71177), New York

19104

RECRUITING

University of Pennsylvania Medical Center (Site #: 71111), Philadelphia

02114

RECRUITING

Massachusetts General Hospital: Transplantation (Site #: 71107), Boston

All Listed Sponsors
collaborator

University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)

UNKNOWN

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH