IVIG for Infection Prevention After CAR-T-Cell Therapy

Inclusion Criteria:

• Capable of understanding the investigational nature, potential risks and benefits ofthe study, and able to provide valid informed consent

• For patients with medical incapacity or impaired consciousness such that they arenot able to give fully informed voluntary consent, the subjects' legalrepresentative must sign an institutional review board (IRB) approved informedconsent document prior to the initiation of any screening or study-specificprocedures

• Participants must be 18 years of age or older

• Participants will receive an Food and Drug Administration (FDA)-approved CD19-CART-cell product for the treatment of hematologic malignancies. Patients receiving anFDA-approved product are eligible even if the product is being administered as partof a clinical trial or expanded access program (e.g., product is 'out ofspecification'; concomitant anti-tumor treatment such as acalabrutinib)

• Serum total IgG < 600mg/dL within the prior three months

• SUBSEQUENT INFUSIONS: Received an FDA-approved CD19-CAR T-cell product for thetreatment 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, orother circumstance that might confound the results of the study or interfere withthe patient's ability to participate for the full duration of the study or would putthe patient at undue risk as judged by the investigator, such that it is not in thebest interest of the patient to participate in this study

• SUBSEQUENT INFUSIONS: Ongoing symptoms of cytokine release syndrome (CRS) and/orimmune effector cell-associated neurotoxicity syndrome (ICANS) meeting criteria forgrade 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 studyor interfere with the patient's ability to participate for the full duration of thestudy or would put the patient at undue risk as judged by the Investigator, suchthat 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 ofthe patient's primary malignancy

• SUBSEQUENT INFUSIONS: Receipt of bone marrow transplant (allogeneic or autologous)

• SUBSEQUENT INFUSIONS: Any serious adverse event (SAE), clinically significantadverse event (AE), severe laboratory abnormality, intercurrent illness, or othermedical condition that indicates to the Investigator that continued participation isnot in the best interest of the participant