CAR T-cell therapy for patients with kidney issues
Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
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 |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, prednisone, CAR T |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05909059 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with active uncontrolled infections, significant CNS disorders, or those on high-dose corticosteroids may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Atlanta, Georgia
- Caitlin Guzowski — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Melhem Solh, MD
- Email: msolh@bmtga.com
- Phone: 404-255-1930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.