Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

IVIG for Infection Prevention After CAR-T-Cell Therapy

NCT05952804 · View on ClinicalTrials.gov ↗

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

319 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05952804

The ClinicalTrials.gov registry entry for NCT05952804 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05952804 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05952804?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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