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Recruiting Phase 2 NCT05909059

CAR T-cell Therapy in Patients With Renal Dysfunction

Phase 2 – studying effectiveness and dosage
Conditions: Non-hodgkin Lymphoma,B Cell Multiple Myeloma Acute Lymphoblastic Leukemia, Adult

Sponsor: Northside Hospital, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Fludarabine
DRUG
Cyclophosphamide
DRUG
Locations 1
United States (1)
Caitlin Guzowski
Atlanta , Georgia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.11.2024
Completion date
31.08.2027
Registry ID
NCT05909059
Source
clinicaltrials.gov
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