RecruitingPhase 2NCT05909059

CAR T-cell Therapy in Patients With Renal Dysfunction

Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction


Sponsor

Northside Hospital, Inc.

Enrollment

20 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the safety and outcomes of CAR T-cell therapy (an advanced immune cell treatment) in patients with blood cancers — including multiple myeloma, leukemia, or lymphoma — who also have reduced kidney function. CAR T-cell therapy is typically given primarily to patients with normal kidney function, and this study aims to understand if it can be safely offered to those with kidney problems. **You may be eligible if...** - You are receiving CAR T-cell therapy for multiple myeloma, leukemia, or lymphoma - Your kidney function is reduced (eGFR below 60 mL/min/1.73m²) - You have adequate bone marrow function to receive the preparatory chemotherapy - Your general health is reasonably good (ECOG 0–2) **You may NOT be eligible if...** - You have significant brain or nervous system disorders - You have an uncontrolled active infection or serious concurrent illness - You are on high-dose steroids (more than 20 mg prednisone per day) within 72 hours before your CAR T-cell infusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFludarabine

Received IV on Days -5 to -3 before CAR T cell therapy

DRUGCyclophosphamide

Received IV on Days -5 to -3 before CAR T cell therapy


Locations(1)

Caitlin Guzowski

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05909059


Related Trials