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
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 20, 2026
April 1, 2026
1.8 years
June 9, 2023
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of CRS
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
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
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
90 days
Study Arms (3)
Moderate Renal Dysfunction
EXPERIMENTALModerate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Severe Renal Dysfunction
EXPERIMENTALSeveral renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Dialysis Participants
EXPERIMENTALParticipants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
Interventions
Received IV on Days -5 to -3 before CAR T cell therapy
Received IV on Days -5 to -3 before CAR T cell therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caitlin Guzowski
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2023
First Posted
June 18, 2023
Study Start
November 18, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04