CAR T-cell Therapy in Patients With Renal Dysfunction

Multiple Myeloma Clinical Trial

Official title:

Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05909059
• Other study ID #: NSH 1375
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Northside Hospital, Inc.
• Contact: Melhem Solh, MD
• Phone: 404-255-1930
• Email: msolh[@]bmtga.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Adult
• Lymphoma, B-Cell
• Multiple Myeloma
• Non-hodgkin Lymphoma,B Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Renal Insufficiency

Intervention

Drug:
• Fludarabine
Received IV on Days -5 to -3 before CAR T cell therapy
• Cyclophosphamide
Received IV on Days -5 to -3 before CAR T cell therapy

Locations

Country	Name	City	State
United States	Caitlin Guzowski	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Northside Hospital, Inc.	Blood and Marrow Transplant Group of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of CRS	Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion	90 days
Primary	Occurrence of ICANS	Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion	90 days
Primary	Occurrence of Cytopenias	Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion	90 days