CAR T-cell Therapy in Patients With Renal Dysfunction

• Sponsor: Northside Hospital, Inc. (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05909059
• Collaborator: Blood and Marrow Transplant Group of Georgia (Other)
• Enrollment: 20
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-hodgkin Lymphoma,B Cell; Multiple Myeloma; Acute Lymphoblastic Leukemia, Adult	Drug: Fludarabine; Drug: Cyclophosphamide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
• Anticipated Study Start Date: Aug 31, 2023
• Anticipated Primary Completion Date: Aug 31, 2025
• Anticipated Study Completion Date: Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Renal Dysfunction Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.	Drug: Fludarabine; Received IV on Days -5 to -3 before CAR T cell therapy; Drug: Cyclophosphamide; Received IV on Days -5 to -3 before CAR T cell therapy
Experimental: Severe Renal Dysfunction Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.	Drug: Fludarabine; Received IV on Days -5 to -3 before CAR T cell therapy; Drug: Cyclophosphamide; Received IV on Days -5 to -3 before CAR T cell therapy
Experimental: Dialysis Participants Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.	Drug: Fludarabine; Received IV on Days -5 to -3 before CAR T cell therapy; Drug: Cyclophosphamide; Received IV on Days -5 to -3 before CAR T cell therapy

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caitlin Guzowski	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Northside Hospital, Inc.
• Blood and Marrow Transplant Group of Georgia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northside Hospital, Inc.
• ClinicalTrials.gov Identifier: NCT05909059
• Other Study ID Numbers: NSH 1375
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell; Renal Insufficiency; Cyclophosphamide; Fludarabine

Study Results

No Results Posted as of Jun 18, 2023