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NCT Number: NCT05909059

CAR T-cell Therapy in Patients With Renal Dysfunction

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.

Recruiting

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Key information

Conditions

Non-hodgkin Lymphoma,B Cell Acute Lymphoblastic Leukemia, Adult Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Precursor Cell Lymphoblastic Leukemia-Lymphoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Caitlin Guzowski

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Location contact

Asad Bashey, MD

SUB_INVESTIGATOR

Caitlin Guzowski, MBA, MHA

CONTACT

[email protected]

404-851-8523

H. Kent Holland, MD

SUB_INVESTIGATOR

Lawrence E Morris, MD

SUB_INVESTIGATOR

Lizamarie Bachier-Rodriguez, MD

SUB_INVESTIGATOR

Melhem Solh, MD

PRINCIPAL_INVESTIGATOR

Scott Solomon, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Occurrence of CRS

    Time frame: 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

    Time frame: 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

    Time frame: 90 days

    Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Guzowski, MBA, MHA

CONTACT

[email protected]

404-851-8523

Melhem Solh, MD

CONTACT

[email protected]

404-255-1930

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Blood and Marrow Transplant Group of Georgia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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