CAR T-cell Therapy in Patients With Renal Dysfunction

• Status: Not yet recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Collaborator: Blood and Marrow Transplant Group of Georgia
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

• Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma

• Adequate bone marrow function to receive lymphodepleting chemotherapy

• Renal function
• ECOG 0-2

Exclusion Criteria:

• Relative CNS disorders

• Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator

• Use of therapeutic dose systemic corticosteroids (defined as >20mg/day prednisone or equivalent) within 72 hours of CAR-T administration