Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies
Condition: Secondary Immune Deficiency · Sponsor: CSL Behring
About this study
This is a prospective, multicenter, open-label, single-arm study to assess the efficacy, safety, and pharmacokinetics (PK) of IgPro20 in adults with hematologic malignancies treated with B-cell targeting Chimeric antigen receptor T-cell (CAR T-cell) and T-cell redirecting therapies (such as T-cell engager bispecific antibody \[TCE BsAb\] therapy). The primary objective is to demonstrate that true annualized rate of serious bacterial infection (SBIs) is less than (\<) 1.0. This study includes two cohorts: 1. Loading Cohort: Participants with serum immunoglobulin G (IgG) \< 500 milligrams per deciliter (mg/dL) at Screening, with or without ongoing immunoglobulin replacement therapy (IgRT) during Screening, who must have received five doses of IgPro20 during the Initial Treatment Period. 2. Maintenance-only Cohort: Participants with serum IgG greater than or equal to (≥) 500 mg/dL and ongoing IgRT at Screening, who must have received one dose of IgPro20 during the Initial Treatment Period.
This description comes directly from the study's public registry record.
Talk to the study team
Trial Registration Coordinator · +16108784697 · clinicaltrials@cslbehring.com
Always discuss trial participation with your own doctor first.
Locations (60)
| UC Irvine | Orange, California, United States | — |
| CBCI, Colorado Blood Cancer Institute | Denver, Colorado, United States | — |
| SSAK Partners | Coral Springs, Florida, United States | — |
| Mayo Clinic - Jacksonville | Jacksonville, Florida, United States | — |
| Indiana University Health Arnett, Inc. | Lafayette, Indiana, United States | — |
| Johns Hopkins Asthma & Allergy Center | Baltimore, Maryland, United States | — |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders | Bethesda, Maryland, United States | — |
| Hackensack Meridian Health | Hackensack, New Jersey, United States | — |
| Carol G Simon Cancer Center | Morristown, New Jersey, United States | — |
| David H. Koch Center for Cancer Care | New York, New York, United States | — |
| Montefiore Medical Center PRIME | The Bronx, New York, United States | — |
| Duke University | Durham, North Carolina, United States | — |
+ 48 more locations — full list on the registry record.
Follow this study
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07648264