NCT05909059 · Northside Hospital, Inc.
CAR T-cell Therapy in Patients With Renal Dysfunction
What this study is about
This is a forward-looking, 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.
View original scientific description
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.
Interventions
DRUG
Fludarabine
Received IV on Days -5 to -3 before CAR T cell therapy
DRUG
Cyclophosphamide
Received IV on Days -5 to -3 before CAR T cell therapy
Primary outcome measures
Occurrence of CRS
Time frame: 90 days
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
Occurrence of ICANS
Time frame: 90 days
Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion
Occurrence of Cytopenias
Time frame: 90 days
Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
Where
- Atlanta, Georgia
Collaborators
Blood and Marrow Transplant Group of Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations