CAR T-cell Therapy in Patients With Renal Dysfunction

Sponsor: Northside Hospital, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05909059

This study evaluates the feasibility of CAR T-cell therapy in patients with moderate to severe renal impairment. Eligible participants must have adequate bone marrow function and renal function ≤60 mL/min/1.73m², with an ECOG score of 0-2. Interventions include IV administration of Fludarabine and Cyclophosphamide on Days -5 to -3 before CAR T-cell therapy.

Patient Parameters

Program Overview

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.

Eligibility 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 </= 60mL/min/1.73m2
  • 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

Locations

FACILITYZIPCITYSTATE
Caitlin Guzowski30342AtlantaGeorgia

Get This Program In Your Inbox

You can sign up and apply your patients for this program.