CAR T-cell Therapy in Patients With Renal Dysfunction

Phase 2

Recruiting

• Conditions: Non-hodgkin Lymphoma,B Cell; Acute Lymphoblastic Leukemia, Adult; Multiple Myeloma
• Interventions: Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT05909059
• Lead Sponsor: Northside Hospital, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Study Start: 2024-11-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe Renal Dysfunction	Cyclophosphamide	Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Moderate Renal Dysfunction	Fludarabine	Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Dialysis Participants	Cyclophosphamide	Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
Severe Renal Dysfunction	Fludarabine	Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Moderate Renal Dysfunction	Cyclophosphamide	Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Dialysis Participants	Fludarabine	Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.

Primary Outcome Measures

Name	Time	Method
Occurrence of CRS	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	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	90 days	Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion

Trial Locations

Locations (1)

Caitlin Guzowski; 🇺🇸 Atlanta, Georgia, United States