eligibility_summary
Eligible: adults ≥18 able to consent (or LAR), with hematologic malignancy receiving FDA‑approved CD19 CAR‑T and serum IgG <600 mg/dL in past 3 months, subsequent infusions require prior FDA‑approved CD19 CAR‑T. Exclude: congenital selective IgA deficiency, prior serious IVIG reaction/allergy, investigator‑judged undue risk, for subsequent infusions: grade ≥3 CRS/ICANS, new anti‑cancer therapy, bone marrow transplant, or significant AEs/labs/illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II randomized trial testing IVIG vs placebo in adults receiving anti‑CD19 CAR‑T for hematologic malignancies. Interventions: 1) IVIG (Immune Globulin Infusion [Human], 10% solution, biologic antibody replacement) given IV before and monthly after CAR‑T, 2) Placebo (normal saline). Mechanisms: IVIG provides passive immunity with pooled polyclonal IgG that neutralizes pathogens, opsonizes via Fcγ receptors, and activates complement, also immunomodulatory. CAR‑T is a cellular immunotherapy of autologous T cells engineered with a CD19 CAR to recognize and kill CD19+ B cells. Targets/pathways: CD19 on malignant and normal B cells (CAR‑T), leading to B‑cell aplasia and hypogammaglobulinemia, humoral immunity pathways (IgG/FcγR/complement) restored by IVIG to prevent infections.