OncoMatch/Clinical Trials/NCT05952804
IVIG for Infection Prevention After CAR-T-Cell Therapy
Is NCT05952804 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Immune Globulin Infusion (Human), 10% Solution and Anti-CD19 CAR T Cells Preparation for hematologic malignancies.
Treatment: Immune Globulin Infusion (Human), 10% Solution · Anti-CD19 CAR T Cells Preparation — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: IGHG1 expression (<600 mg/dL within prior three months)
Serum total IgG < 600mg/dL within the prior three months
Prior therapy
Must have received: CAR-T cell therapy (CD19-CAR T-cell product) — hematologic malignancy
Participants will receive an FDA-approved CD19-CAR T-cell product for the treatment of hematologic malignancies
Cannot have received: bone marrow transplant
Receipt of bone marrow transplant (allogeneic or autologous) after CARTx
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Cancer Center · Duarte, California
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, Florida
- Moffitt Cancer Center · Tampa, Florida
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05952804 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bone marrow transplant disqualifies patients from enrollment.
Does this trial require IGHG1?
Yes, IGHG1 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify