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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
IgPro20 infusion administered SC.
UC Irvine
Orange, California, United States
NOT_YET_RECRUITINGCBCI, Colorado Blood Cancer Institute
Denver, Colorado, United States
NOT_YET_RECRUITINGSSAK Partners
Coral Springs, Florida, United States
RECRUITINGMayo Clinic - Jacksonville
Jacksonville, Florida, United States
Number of Serious Bacterial Infections (SBIs) per Participant
The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
Time frame: Up to Month 12
Number of Infections per Participant
Time frame: Up to Month 12
Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant
As per CTCAE, Grade 3 is defined as Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to adverse event. Infections of CTCAE Grade 3 or worse will be reported.
Time frame: Up to Month 12
Number of Days Hospitalized due to Infections
Time frame: Up to Month 12
Number of Days With Anti-infectives Use
Time frame: Up to Month 12
Number of Infection-related Deaths and Complications
Time frame: Up to Month 12
Number of Infection-related Requirement for Intravenous (IV) Therapy
Time frame: Up to Month 12
Number of Infection-related Requirement for Hospitalization per Participant
Time frame: Up to Month 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Infusion Site Reaction and Other Local Reactions
In this study, thromboembolic events are treated as AESIs. The following 3 narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) queries are used for TEE evaluation: * Embolic and thrombotic events, arterial * Embolic and thrombotic events, venous * Embolic and thrombotic events, vessel type unspecified, and mixed arterial and venous.
Time frame: Up to Month 12
Trough Concentrations of Serum IgG
Time frame: Up to Week 56
Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t])
Time frame: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Maximal Serum Concentration (Cmax) of IgG
Time frame: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Time to Maximal Serum Concentration (Tmax) of IgG
Time frame: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
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Indiana University Health Arnett, Inc.
Lafayette, Indiana, United States
NOT_YET_RECRUITINGJohns Hopkins Asthma & Allergy Center
Baltimore, Maryland, United States
NOT_YET_RECRUITINGAmerican Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
RECRUITINGHackensack Meridian Health
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGCarol G Simon Cancer Center
Morristown, New Jersey, United States
NOT_YET_RECRUITINGDavid H. Koch Center for Cancer Care
New York, New York, United States
NOT_YET_RECRUITING...and 50 more locations