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CAR T-cell Therapy in Patients With Renal Dysfunction

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment20 people
  • Recruiting US sites1
  • SponsorNorthside Hospital, Inc.
  • RegistryNCT05909059

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

CAR T-cell Therapy in Patients With Renal Dysfunction: a one-minute explainerNCT059090591 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

fludarabine phosphate. The phosphate salt of a fluorinated nucleotide antimetabolite analog of the antiviral agent vidarabine (ara-A) with antineoplastic activity. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite may inhibit DNA polymerase alpha, ribonucleotide reductase and DNA primase, thereby interrupting DNA synthesis and inhibiting tumor cell growth. NCI Drug Dictionary

CAF regimen. A regimen consisting of oral cyclophosphamide, doxorubicin and fluorouracil, used as a treatment for recurrent and metastatic breast cancer. NCI Drug Dictionary

Treatments listed in the registry

  • 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

The study

Treatment groups

Non Randomized · Single Group · masking: None

Moderate Renal Dysfunction (Experimental)

Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

Severe Renal Dysfunction (Experimental)

Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

Dialysis Participants (Experimental)

Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.

Goals

What the study measures

Main goals

  • Occurrence of CRS (90 days)
  • Occurrence of ICANS (90 days)
  • Occurrence of Cytopenias (90 days)

Planned enrollment: 20 (estimated).

Where

Recruiting US sites

  • Caitlin Guzowski, Atlanta, Georgia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 13, 2026. Public record; not medical advice.

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