Measuring the Impact of Immunoglobulin Therapy on Infection Prevention After CAR-T Therapy
NCT05952804 · RecruitingThis trial looks at how well immunoglobulin replacement therapy can help prevent infections after patients receive CAR-T cell therapy for blood cancers. CAR-T therapy can lower the body's antibodies, which are important for fighting infections. By giving immunoglobulin therapy, the hope is to keep patients safe from infections during treatment.
Locations and contact
This trial is running at 7 locations in the United States. All of them are currently recruiting.
United States7 locations · 7 recruiting
- City of Hope Cancer CenterDuarte, CaliforniaRecruiting
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, WashingtonRecruiting
- Massachusetts General Hospital Cancer CenterBoston, MassachusettsRecruiting
- Memorial Sloan Kettering Cancer CenterNew York, New YorkRecruiting
- Moffitt Cancer CenterTampa, FloridaRecruiting
- Oregon Health and Science University (OHSU) Knight Cancer InstitutePortland, OregonRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, FloridaRecruiting
Who can join
Men and women aged 18 and older can join. Participants should be able to understand the study and give consent. They must be receiving an FDA-approved CD19 CAR-T product for blood cancers. Some health issues may prevent participation. The trial team will confirm eligibility before joining.
What happens during the trial
Participants are randomly placed into one of two groups. In one group, patients get immunoglobulin therapy before and after CAR-T treatment. In the other group, patients receive a placebo (normal saline) instead. Both groups will have monthly treatments for four months after their CAR-T therapy, along with blood sample collections throughout the study.
The trial team
The trial is sponsored by Fred Hutchinson Cancer Center. Collaborators include Takeda and the National Cancer Institute. Joshua Hill, MD, is the principal investigator leading the study.
Important dates
The trial started on June 10, 2024, and is expected to finish by July 31, 2028. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT05952804. This is a Phase 2 trial, which means it is studying the effectiveness and safety of the treatment. It is regulated by the FDA and aims to include about 150 participants.
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