CAR T-cell Therapy in Patients With Renal Dysfunction

Last updated: April 11, 2025
Sponsor: Northside Hospital, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Failure (Pediatric)

Lymphocytic Leukemia, Acute

Red Blood Cell Disorders

Treatment

Cyclophosphamide

Fludarabine

Clinical Study ID

NCT05909059
NSH 1375
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Adequate bone marrow function to receive lymphodepleting chemotherapy

  • Renal function </= 60mL/min/1.73m2

  • ECOG 0-2

Exclusion

Exclusion Criteria:

  • Relative CNS disorders

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

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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Cyclophosphamide
Phase: 2
Study Start date:
November 18, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Caitlin Guzowski

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.