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CAR T-cell Therapy in Patients With Renal Dysfunction
NCT05909059 · Northside Hospital, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
About this study
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
Study design
Enrollment target: 20 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-18
Estimated completion: 2027-08-31
Last updated: 2025-10-30
Interventions
Drug: FludarabineDrug: Cyclophosphamide
Primary outcomes
- • Occurrence of CRS (90 days)
- • Occurrence of ICANS (90 days)
- • Occurrence of Cytopenias (90 days)
Sponsor
Northside Hospital, Inc. · other
With: Blood and Marrow Transplant Group of Georgia
Contacts & investigators
ContactMelhem Solh, MD · contact · msolh@bmtga.com · 404-255-1930
ContactCaitlin Guzowski, MBA, MHA · contact · caitlin.guzowski@northside.com · 404-851-8523
All locations (1)
Caitlin GuzowskiRecruiting
Atlanta, Georgia, United States