Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Hematologic Malignancies, sponsored by Fred Hutchinson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Grade 2 or 3 bacterial infections. Only microbiologically confirmed infections will be included. Microbiological documentation of an infection consists of isolation of the pathogen by culture from a sterile (definite) or nonsterile (probable) site (if from a nonsterile site, the organism had to be clinically judged to be pathogenic). Will describe the number and type of infections in each study arm and calculate incidence rate estimates and 95% confidence intervals (CIs) for infections. Will com
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT05952804 shows while recruiting
NCT05952804 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 2,709-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (94% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Hematologic Malignancies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05952804's enrollment target sits among peer trials
150 13th of 45 higher than 33 of 45 other Hematologic Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
RECRUITING · Phase 2
-
A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
RECRUITING · Phase 2
-
Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation
RECRUITING · Phase 2
-
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
RECRUITING · Phase 2
-
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
RECRUITING · Phase 2
-
Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies with Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI