Using immunoglobulin therapy to prevent infections after CAR-T cell treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of immunoglobulin replacement therapy compared to a placebo in preventing infections in patients undergoing CD19 CAR-T cell therapy for hematologic malignancies. Patients are randomly assigned to receive either intravenous immune globulin (IVIG) or a placebo prior to and following their CAR-T cell infusion. The study aims to address hypogammaglobulinemia, a common complication that increases infection risk in these patients, by providing additional IgG antibodies. Participants will be monitored for up to six months post-treatment to assess the incidence of infectious complications.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Cancer Center
  Duarte, California, United States Recruiting
• University of Miami Miller School of Medicine-Sylvester Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Massachusetts General Hospital Cancer Center
  Boston, Massachusetts, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Oregon Health and Science University (OHSU) Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Joshua Hill, MD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Joshua Hill, MD
• Email: jahill@fredhutch.org
• Phone: 206-667-6504

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.