CAR T-cell Therapy in Patients With Renal Dysfunction

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT05909059
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 18, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate Renal Dysfunction
    Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
  • Experimental: Severe Renal Dysfunction
    Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
  • Experimental: Dialysis Participants
    Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.

Primary Outcome Measure

Occurrence of CRS [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Caitlin GuzowskiAtlantaGeorgia30342
Caitlin Guzowski, MBA, MHA
[email protected]
404-851-8523
H. Kent Holland, MD (SUB_INVESTIGATOR)
Asad Bashey, MD (SUB_INVESTIGATOR)
Lawrence E Morris, MD (SUB_INVESTIGATOR)
Scott Solomon, MD (SUB_INVESTIGATOR)
Melhem Solh, MD (PRINCIPAL_INVESTIGATOR)
Lizamarie Bachier-Rodriguez, MD (SUB_INVESTIGATOR)

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