CAR T-cell Therapy in Patients With Renal Dysfunction

NCT ID: NCT05909059

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2027-08-31

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.

Conditions

Non-hodgkin Lymphoma,B Cell; Multiple Myeloma; Acute Lymphoblastic Leukemia, Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate Renal Dysfunction

Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Cyclophosphamide

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Severe Renal Dysfunction

Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Cyclophosphamide

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Dialysis Participants

Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Cyclophosphamide

Intervention Type: DRUG

Received IV on Days -5 to -3 before CAR T cell therapy

Interventions

Fludarabine

Received IV on Days -5 to -3 before CAR T cell therapy

Intervention Type: DRUG

Cyclophosphamide

Received IV on Days -5 to -3 before CAR T cell therapy

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blood and Marrow Transplant Group of Georgia

OTHER

Sponsor Role: collaborator

Northside Hospital, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Caitlin Guzowski

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melhem Solh, MD

Role: CONTACT

msolh@bmtga.com

404-255-1930

Caitlin Guzowski, MBA, MHA

Role: CONTACT

caitlin.guzowski@northside.com

404-851-8523

Facility Contacts

Caitlin Guzowski, MBA, MHA

Role: primary

caitlin.guzowski@northside.com

404-851-8523

Other Identifiers

NSH 1375

Identifier Type: -

Identifier Source: org_study_id