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NCT05952804Not yet recruiting

IVIG for Infection Prevention After CAR-T-Cell Therapy

Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy
Fred Hutchinson Cancer CenterPhase 2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Lymphoma
Drug/Device/Intervention
Immune Globulin Infusion (Human), 10% Solution
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Fred Hutchinson Cancer Center
Location
Seattle, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 01, 2023
End date
Jul 31, 2028
Enrollment
150 participants
Primary outcome

Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population

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.

ICD-10 classifications
Hodgkin lymphomaFollicular lymphomaNon-Hodgkin lymphoma, unspecifiedFollicular lymphoma, unspecifiedHodgkin lymphoma, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05952804
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05952804 through Pure Global AI's free database. This Phase 2 trial is sponsored by Fred Hutchinson Cancer Center and is currently Not yet recruiting. The study focuses on Lymphoma. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.