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NCT05909059PHASE2Recruiting

CAR T-cell Therapy in Patients With Renal Dysfunction

Northside Hospital, Inc.

Start Date

11/18/2024

Completion Date

8/31/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Fludarabine

DRUG

Cyclophosphamide

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Conditions

Non-hodgkin Lymphoma,B CellMultiple MyelomaAcute Lymphoblastic Leukemia, Adult

Locations

Caitlin Guzowski

Atlanta, Georgia 30342

United States