CAR T-cell Therapy in Patients With Renal Dysfunction

Northside Hospital, Inc.

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT05909059

NSH 1375

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Moderate Renal Dysfunction

Experimental group

Description:

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

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Severe Renal Dysfunction

Experimental group

Description:

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

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Dialysis Participants

Experimental group

Description:

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

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide