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A Phase 3, Prospective, Open-label, Multicenter, Single-arm Study to Investigate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Subjects with Secondary Immune Deficiency due to Hematologic Malignancies Treated with B-cell Targeting Chimeric Antigen Receptor T-Cell and T-Cell Redirecting Therapies

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525626-38-00
Enrollment
21
Registered
2026-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Immune Deficiency

Brief summary

Number of Serious Bacterial Infections (SBIs) per Participant The SBIs includes: bacteraemia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.

Detailed description

Number of Infections per Participant, Number CTCAE >= Grade 3 Infections per Participant. Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling limiting self-care activities of daily living. Infections of CTCAE Grade 3 or worse will be reported., Number of Days Hospitalized due to Infections, Number of Days With Anti-infectives Use, Number of Infection-related Deaths and Complications, Number of Infection-related Requirement for Intravenous (IV)Therapy, Number of Infection-related Requirement for Hospitalization per Participant, Number of Participants with TEAEs, Serious Adverse SAEs, AESIs, Infusion Site Reaction and Other Local Reactions. In this study, thromboembolic events are treated as AESIs., Trough Concentrations of Serum IgG, Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau(AUC[0-t]), Maximal Serum Concentration (Cmax) of IgG, Time to Maximal Serum Concentration (Tmax) of IgG

Interventions

Sponsors

CSL Behring LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Serious Bacterial Infections (SBIs) per Participant The SBIs includes: bacteraemia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.—

Secondary

MeasureTime frame
Number of Infections per Participant, Number CTCAE >= Grade 3 Infections per Participant. Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling limiting self-care activities of daily living. Infections of CTCAE Grade 3 or worse will be reported., Number of Days Hospitalized due to Infections, Number of Days With Anti-infectives Use, Number of Infection-related Deaths and Complications, Number of Infection-related Requirement for Intravenous (IV)Therapy, Number of Infection-related Requirement for Hospitalization per Participant, Number of Participants with TEAEs, Serious Adverse SAEs, AESIs, Infusion Site Reaction and Other Local Reactions. In this study, thromboembolic events are treated as AESIs., Trough Concentrations of Serum IgG, Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau(AUC[0-t]), Maximal Serum Concentration (Cmax) of IgG, Time to Maximal Serum Con—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 21, 2026