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
Public ClinicalTrials.gov record NCT07648264. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07648264
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2026 (Actual)
- Primary completion
- Sep 27, 2029 (Estimated)
- Completion
- Sep 27, 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Irvine | Orange | California | 92868 | Not yet recruiting |
| CBCI, Colorado Blood Cancer Institute | Denver | Colorado | 80218 | Not yet recruiting |
| SSAK Partners | Coral Springs | Florida | 33065 | Recruiting |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | Not yet recruiting |
| Indiana University Health Arnett, Inc. | Lafayette | Indiana | 47904 | Not yet recruiting |
| Johns Hopkins Asthma & Allergy Center | Baltimore | Maryland | 21224 | Not yet recruiting |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | Recruiting |
| Hackensack Meridian Health | Hackensack | New Jersey | 07601 | Not yet recruiting |
| Carol G Simon Cancer Center | Morristown | New Jersey | 07960 | Not yet recruiting |
| David H. Koch Center for Cancer Care | New York | New York | 10065 | Not yet recruiting |
| Montefiore Medical Center PRIME | The Bronx | New York | 10467 | Not yet recruiting |
| Duke University | Durham | North Carolina | 27710 | Not yet recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | Not yet recruiting |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Not yet recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | Not yet recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07648264, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07648264 live on ClinicalTrials.gov.