RecruitingPhase 2NCT05952804

IVIG for Infection Prevention After CAR-T-Cell Therapy

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


Sponsor

Fred Hutchinson Cancer Center

Enrollment

150 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Anti-CD19 CAR T Cells Preparation, a procedure called Biospecimen Collection, and others for people with hematologic malignancies. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALImmune Globulin Infusion (Human), 10% Solution

Given IV

BIOLOGICALAnti-CD19 CAR T Cells Preparation

Given CAR-T treatment

OTHERSaline

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERSurvey Administration

Ancillary studies

OTHERElectronic 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

View Full Details on ClinicalTrials.gov

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NCT05952804


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