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CAR T-cell Therapy for Blood Cancers with Kidney Problems

This study is looking at how safe and possible it is to give CAR T-cell therapy to people with certain blood cancers (Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Lymphoblastic Leukemia) who also have moderate to severe kidney problems. You would receive chemotherapy drugs, Fludarabine and Cyclophosphamide, before getting CAR T-cell therapy. The study wants to see if this treatment causes side effects like cytokine release syndrome (CRS), ICANS (a type of brain-related side effect), or low blood counts (cytopenias) within 90 days. To join, you must be receiving CAR T-cell therapy for one of these cancers, have good bone marrow function, and have kidney function at or below 60mL/min/1.73m2. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is a prospective, descriptive study, meaning researchers will observe and describe what happens to participants. It plans to enroll 20 participants.
What's involved
You would receive lymphodepleting chemotherapy (Fludarabine and Cyclophosphamide) before CAR T-cell therapy. The study will monitor for side effects for 90 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days to check for primary endpoints like CRS, ICANS, and cytopenias.

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NCT05909059

CAR T-cell Therapy in Patients With Renal Dysfunction

Recruiting
PHASE2Ages 18+InterventionalTreatment
Northside Hospital, Inc.
~20 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of CRS
Measured over 90 days
+2 more outcomes measured

Conditions

Non-hodgkin Lymphoma,B Cell
Multiple Myeloma
Acute Lymphoblastic Leukemia, Adult

Explore related trials

Acute Lymphoblastic LeukemiaMultiple MyelomaNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Georgia1

Who to contact

Melhem Solh, MD
[email protected]
404-255-1930
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Occurrence of CRS90 days

    Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion

  • Occurrence of ICANS90 days

    Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion

  • Occurrence of Cytopenias90 days

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