CAR T-cell therapy for patients with kidney issues
Official title: Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
Run by Northside Hospital, Inc. · NCT05909059 · Data updated 2026-11-12
This study is testing if CAR T-cell therapy can be safely given to patients with kidney problems who are getting chemotherapy for blood cancers like multiple myeloma, leukemia, or lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, prednisone, CAR T |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT05909059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with moderate to severe renal impairment and adequate bone marrow function who are receiving lymphodepleting chemotherapy for specific blood cancers.
✕Probably not a fit
Patients with active uncontrolled infections, significant CNS disorders, or those on high-dose corticosteroids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility of administering CAR T-cell therapy to patients with moderate to severe renal impairment who are undergoing lymphodepleting chemotherapy for conditions like multiple myeloma, leukemia, or lymphoma. The approach involves adjusting the chemotherapy dosage to accommodate the patients' renal function. The study aims to determine how well these patients can tolerate the treatment and its effectiveness in managing their conditions.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with renal dysfunction who have limited choices for managing their hematological cancers.
How similar studies have gone: While CAR T-cell therapy has shown success in various populations, this specific approach for patients with renal impairment is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Caitlin Guzowski
Atlanta, Georgia, United States Recruiting
Study contacts
- Study coordinator: Melhem Solh, MD
- Email: msolh@bmtga.com
- Phone: 404-255-1930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.