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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05909059
Other study ID # NSH 1375
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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