Recruiting
Phase 2

IVIG

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT05952804

Conditions

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immune Globulin Infusion (Human), 10% Solution

Anti-CD19 CAR T Cells Preparation

Saline

Biospecimen Collection

Survey Administration

Study Details

Brief 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

Hematologic Malignancies

Study ID

NCT05952804

Start date

Jun 10, 2024

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
  • For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative must sign an institutional review board (IRB) approved informed consent document prior to the initiation of any screening or study-specific procedures
  • Participants must be 18 years of age or older
  • Participants will receive an Food and Drug Administration (FDA)-approved CD19-CAR T-cell product for the treatment of hematologic malignancies. Patients receiving an FDA-approved product are eligible even if the product is being administered as part of a clinical trial or expanded access program (e.g., product is 'out of specification'; concomitant anti-tumor treatment such as acalabrutinib)
  • Serum total IgG < 600mg/dL within the prior three months

  • Note, if there are additional results ≥ 600 mg/dL within the prior three months, but the patient is receiving IVIG, they remain eligible
  • SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies

Exclusion Criteria:

  • Primary congenital selective IgA deficiency
  • Prior serious adverse event/s related to intravenous immune globulin (IVIG) administration
  • Known serious allergy to any component of IVIG
  • Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the investigator, such that it is not in the best interest of the patient to participate in this study
  • SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria for grade 3 or higher
  • SUBSEQUENT INFUSIONS: Primary congenital selective IgA deficiency
  • SUBSEQUENT INFUSIONS: Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study or interfere with the patient's ability to participate for the full duration of the study or would put the patient at undue risk as judged by the Investigator, such that it is not in the best interest of the patient to participate in this study
  • SUBSEQUENT INFUSIONS: Receipt of additional therapy for persistence or relapse of the patient's primary malignancy for which they underwent CARTx
  • SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous) after CARTx
  • SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significant adverse event (AE), severe laboratory abnormality, intercurrent illness, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the participant

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm I (therapeutic immune globulin)

Patients receive IGRT with IVIG within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T therapy. Patients receive IVIG monthly, starting 28 days after CD19 CAR-T therapy for 4 months in the absence of unacceptable toxicity. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the study.

placebo comparator: Arm II (normal saline)

Patients receive placebo with normal saline IV within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T therapy. Patients receive normal saline monthly, starting 28 days after CD19 CAR-T therapy for 4 months in the absence of unacceptable toxicity. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the study.

Interventions

Immune Globulin Infusion (Human), 10% Solution

Given IV

Anti-CD19 CAR T Cells Preparation

Given CAR-T treatment

Saline

Given IV

Biospecimen Collection

Undergo blood sample collection

Survey Administration

Ancillary studies

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population [ Time Frame: From randomization through day 168 post chimeric antigen receptor (CAR) T-cell treatment (CARTx) ]

Central Contacts and Locations

Central contacts

Joshua Hill, MD

206-667-6504jahill@fredhutch.org

Locations

City of Hope Cancer Center

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Sanjeet Dadwal, MD

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Jay Spiegel, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Frederick Locke, MD

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Matthew Frigault, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Miguel-Angel Perales, MD

Oregon Health and Science University (OHSU) Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Amrita Desai, MD, MPH

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Joshua Hill, MD

206-667-6504jahill@fredhutch.org

Principal Investigator:

Joshua Hill, MD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-06-29.