Health TrialsbyHealthPanel

CAR T-cell Therapy in Patients With Renal Dysfunction

ConditionsNon-hodgkin Lymphoma,B CellMultiple MyelomaAcute Lymphoblastic Leukemia, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthside Hospital, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Moderate Renal DysfunctionExperimental treatment 2 interventions
Group B: Severe Renal DysfunctionExperimental treatment 2 interventions
Group C: Dialysis ParticipantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of CRS

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

Time frame
90 days
2

Occurrence of ICANS

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

Time frame
90 days
3

Occurrence of Cytopenias

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

Time frame
90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northside Hospital, Inc.

Lead sponsor

Blood and Marrow Transplant Group of Georgia

Collaborator

Source ClinicalTrials.gov
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