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NCT05952804 · ClinicalTrials.gov registry record · Phase 2

IVIG for Infection Prevention After CAR-T-Cell Therapy

A Phase 2 study of Hematologic Malignancies, sponsored by Fred Hutchinson Cancer Center.

Recruiting
Registry status
Phase 2
Development phase
150
Enrollment target
6
Study locations

NCT05952804 is a Phase 2 study of Hematologic Malignancies that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 150 participants, below the 2,709-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT05952804, a Phase 2 study of Hematologic Malignancies, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.

RECRUITING
Registry status
Phase 2
Development phase
150 participants
Enrollment target
6
Study locations

Study 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.

Conditions Studied

Interventions

  • PROCEDURE Biospecimen Collection
  • OTHER Saline
  • OTHER Survey Administration
  • BIOLOGICAL Immune Globulin Infusion (Human), 10% Solution
  • BIOLOGICAL Anti-CD19 CAR T Cells Preparation

Study Locations (6)

California

  • City of Hope Cancer Center - Duarte

Florida

  • Moffitt Cancer Center - Tampa

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston

New York

  • Memorial Sloan Kettering Cancer Center - New York

Oregon

  • Oregon Health and Science University (OHSU) Knight Cancer Institute - Portland

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-06-10
Est. Completion 2028-07-31
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT05952804

The ClinicalTrials.gov registry entry for NCT05952804 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,709-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (94% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematologic Malignancies appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05952804 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05952804 about?

NCT05952804 is a clinical study titled "IVIG for Infection Prevention After CAR-T-Cell Therapy". 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 ther...

What is the current status of trial NCT05952804?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-06-10. Estimated completion is 2028-07-31.

What conditions does trial NCT05952804 study?

This clinical trial studies the following conditions: Hematologic Malignancies.

What interventions are being tested in trial NCT05952804?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Saline (OTHER), Survey Administration (OTHER), Immune Globulin Infusion (Human), 10% Solution (BIOLOGICAL), Anti-CD19 CAR T Cells Preparation (BIOLOGICAL).

Who is sponsoring clinical trial NCT05952804?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05952804 being conducted?

This trial has 6 study locations across California, Florida, Massachusetts, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.