IVIG for Infection Prevention After CAR-T-Cell Therapy

Lymphoma Clinical Trial

Official title: Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy

Status Recruiting

Clinical Trial Summary

This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's IgG antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.

Clinical Trial Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive immunoglobulin replacement therapy (IGRT) with intravenous immune globulin (IVIG) within 14 days prior to CD19 CAR-T-cell infusion. Patients then undergo CD19 CAR-T therapy. Patients receive IVIG monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Patients also undergo blood sample collection throughout the study.

ARM II: Patients receive placebo with normal saline IV within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T-cell infusion. Patients receive normal saline monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Patients also undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up monthly through up to 6 months after CD19 CAR-T-cell infusion. ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT05952804
• Study type: Interventional
• Source: Fred Hutchinson Cancer Center
• Contact: Joshua Hill, MD
• Phone: 206-667-6504
• Email: jahill@fredhutch.org
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2024
• Completion date: July 31, 2028