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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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Sep 11, 2026 to Sep 15, 2026 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 2 of 12 entries · Site details revised at 6 of 60 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 12 entries
    • Site details revised at 6 of 60 sites
  2. Recruitment opened Primary and study completion dates: Feb 16, 2029 to Mar 13, 2029 · Start date: Aug 31, 2026 to Sep 11, 2026 · Site details revised at 60 of 60 sitesv4 Show 3 more changesShow less
    • Primary and study completion dates: Feb 16, 2029 to Mar 13, 2029
    • Start date: Aug 31, 2026 to Sep 11, 2026
    • Site details revised at 60 of 60 sites
  3. Start date: Jul 24, 2026 to Aug 31, 2026v3
  4. Trial sites expanded: 0 → 60 locations Start date: Jul 25, 2026 to Jul 24, 2026v2 Show 1 more changeShow less
    • Start date: Jul 25, 2026 to Jul 24, 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CSL Behring
30 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT07648264
Lead Sponsor CSL Behring
Conditions Secondary Immune Deficiency
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov