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RECRUITING
NCT05952804
PHASE2

IVIG for Infection Prevention After CAR-T-Cell Therapy

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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 immunoglobulin G (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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-06-10

Completion Date

2028-07-31

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Immune Globulin Infusion (Human), 10% Solution

Given IV

BIOLOGICAL

Anti-CD19 CAR T Cells Preparation

Given CAR-T treatment

OTHER

Saline

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Survey Administration

Ancillary studies

OTHER

Electronic Health Record Review

Ancillary studies

Locations (7)

City of Hope Cancer Center

Duarte, California, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, Oregon, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States