Study on Using IVIG to Prevent Infections After CAR-T Cell Therapy
Sponsor: Fred Hutchinson Cancer Center
ClinicalTrials ID:NCT05952804
This clinical trial is testing whether immunoglobulin replacement therapy can help prevent infections in patients undergoing CD19 CAR-T cell therapy, which often lowers antibody levels and increases infection risk.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring whether giving patients immunoglobulin replacement therapy (IVIG) can help prevent infections after they receive CD19 CAR-T cell therapy. CAR-T cell therapy can lower the levels of antibodies in the blood, making patients more prone to infections. IVIG works by providing these antibodies from donor blood, which might help protect against infections.
Description
In this study, patients are divided into two groups.
In Group 1, patients receive immunoglobulin replacement therapy (IVIG) through an IV before starting their CAR-T cell treatment. After the CAR-T cell therapy, they continue to receive IVIG once a month for up to four months, unless they experience severe side effects, their disease returns, or they undergo a bone marrow transplant. Blood samples are collected throughout the study to monitor their health.
In Group 2, patients receive a placebo (a harmless saline solution) through an IV before starting their CAR-T cell treatment. After the CAR-T cell therapy, they continue to receive the placebo once a month for up to four months, under the same conditions as Group 1. Blood samples are also collected from these patients throughout the study.
After finishing the study treatment, all patients are monitored monthly for up to six months after their CAR-T cell therapy to check for any health changes.
Eligibility Criteria
Inclusion Criteria
- Must understand the study and be able to give consent, or have a legal representative do so if unable.
- Must be 18 years or older.
- Must be receiving an FDA-approved CD19 CAR-T cell product for blood cancers, even if part of a clinical trial.
- Must have low antibody levels (IgG less than 600 mg/dL) in the past three months.
- Must have received an FDA-approved CD19 CAR-T cell product for blood cancers.
Exclusion Criteria
- Cannot have a primary congenital selective IgA deficiency.
- Cannot have had serious side effects from IVIG in the past.
- Cannot have a known serious allergy to any part of IVIG.
- Cannot have any condition or situation that might interfere with the study or pose a risk to the patient, as judged by the study doctor.
- Cannot have ongoing severe symptoms from CAR-T cell therapy side effects like cytokine release syndrome or neurotoxicity.
- Cannot have received additional treatment for cancer persistence or relapse.
- Cannot have had a bone marrow transplant.
- Cannot have any serious medical condition or side effect that makes continued participation unsafe, as judged by the study doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Cancer Center | 91010 | Duarte | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.