CAR T-cell Therapy in Patients With Renal Dysfunction

Launched by NORTHSIDE HOSPITAL, INC. · Jun 9, 2023

Keywords

ClinConnect Summary

This clinical trial is evaluating a new treatment called CAR T-cell therapy for patients with certain types of blood cancers, including non-Hodgkin lymphoma, multiple myeloma, and acute lymphoblastic leukemia. The study specifically focuses on patients who have moderate to severe kidney problems, to see if they can safely receive this treatment along with a special type of chemotherapy designed to prepare their bodies for CAR T therapy. The goal is to find out if this approach is feasible and effective for those with reduced kidney function.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and must be receiving specific chemotherapy before starting CAR T therapy. They also need to have enough healthy bone marrow and some level of kidney function (measured as 60 mL/min or less). However, individuals with certain brain disorders, uncontrolled infections, or those using high doses of steroids shortly before treatment will not be included. Participants can expect close monitoring during the trial and will be contributing to important research that may help improve treatment options for others with similar health issues.

Gender

ALL

Eligibility 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