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RecruitingInterventionalPhase 2

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

NCT ID: NCT05909059Sponsor: Northside Hospital, Inc.Last updated: 2026-04-20

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.

Arms & 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

Outcome measures

Primary

  • Occurrence of CRS

    Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion

    Time frame: 90 days

  • Occurrence of ICANS

    Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion

    Time frame: 90 days

  • Occurrence of Cytopenias

    Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion

    Time frame: 90 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Caitlin Guzowski

Atlanta, Georgia, 30342

Recruiting
Caitlin Guzowski, MBA, MHA · Contact
404-851-8523caitlin.guzowski@northside.com
H. Kent Holland, MD · Sub Investigator
Asad Bashey, MD · Sub Investigator
Lawrence E Morris, MD · Sub Investigator
Scott Solomon, MD · Sub Investigator
Melhem Solh, MD · Principal Investigator
Lizamarie Bachier-Rodriguez, MD · Sub Investigator
CAR T-cell Therapy in Patients With Renal Dysfunction | Cancerify