NCT07648264RecruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 27 Sept 2029
- Lead sponsor
- CSL Behring
- NCT number
- NCT07648264
- EU CT number
- 2026-525626-38-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 63
- From 15 Sept 2026 to the primary completion date, 27 Sept 2029
- 60 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of thromboembolic event (TEE) within 6 months before Screening.
- Participants on any prohibited therapies, including anti-infective treatments.
- Concurrent participation in other interventional clinical studies. Note: a participant may be enrolled if their participation in the other study will not jeopardize their safety and / or the scientific validity of this study (eg, an observational study, a long-term safety follow-up of an interventional study, diagnostic device studies, phase 4 studies with medicines used within their approved indication); the investigator may consult with the medical monitor.
Other illness
- Documented history of diseases for which IgRT may be indicated: primary immune deficiency, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, immune thrombocytopenia, Kawasaki disease, Lambert-Eaton myasthenic syndrome, multifocal motor neuropathy, myasthenia gravis, stiff person syndrome, solid organ transplant, and rejection prior to Screening.
- Presence of any systemic active infection at Screening.
Lab values
- Absolute neutrophil count \< 1 × 10\*9/L (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or worse), unless proven to be due to the underlying disease and raised above the limit by granulocyte colony-stimulating factor.
Other
- Eastern Cooperative Oncology Group performance status \> 1.
Who the study is looking for
- Participants greater than or equal to (≥) 18 years of age at the time of providing written informed consent.
- Confirmed diagnosis of B-cell hematologic malignancy (ie, Multiple myeloma \[MM\], Chronic lymphocytic leukemia \[CLL\], Non-Hodgkin lymphoma \[NHL\], or BALL) according to applicable diagnostic criteria.
- Participants treated with Chimeric antigen receptor T-cell (CAR T-cell) therapy or TCE BsAb and are:
- At least 2 months after receipt of an approved CAR T-cell therapy for the B-cell hematologic malignancy at the time of Screening, or
- At least 1 month after initiation of an approved TCE BsAb therapy for the B-cell hematologic malignancy at the time of Screening and expected to continue with the therapy.
- Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening:
- CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria
- MM based on International Myeloma Working Group response criteria
- NHL based on Lugano Classification criteria
- B-ALL based on National Comprehensive Cancer Network guidelines
- IgG level (excluding paraprotein, if relevant) at Screening:
- If participant has ongoing IgRT (intravenous immunoglobulin \[IVIG\] or subcutaneous immunoglobulin \[SCIG\]) for SID during Screening, then any IgG level at Screening is acceptable for enrollment. Participants with IgG less than (\<) 500 milligrams per deciliter (mg/dL) are assigned to the Loading Cohort, participants with IgG ≥ 500 mg/dL are assigned to the Maintenance-only Cohort.
- IgG level (excluding paraprotein, if relevant) at Screening:
- If participant does not have ongoing IgRT (IVIG for \> 8 weeks or SCIG for \> 2 weeks) for SID during Screening and are not expected to receive IgRT during Screening, then IgG \< 500 mg/dL is required for enrollment (participant is assigned to the Loading Cohort)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen (Uza) Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Not yet recruiting |
| Horizon Health Network Coordinator of this site? Confirm its status | Fredericton | Canada | Not yet recruiting |
| McGill University Health Research Institute Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| FH Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| FH Ostrova Coordinator of this site? Confirm its status | Ostrova | Czechia | Not yet recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| UHKT Praha Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Terminated |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Not yet recruiting |
| Department of Medicine, Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Not yet recruiting |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Vall d'Hebron Institut d'Oncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario del Vinalopo Coordinator of this site? Confirm its status | Elche | Spain | Not yet recruiting |
| Pratia ES HLA Hospital Universitario Moncloa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| CHU Angers - Hôpital Hôtel Dieu# Coordinator of this site? Confirm its status | Angers | France | Not yet recruiting |
| Centre Hospitalier Départemental Les Oudairies Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Not yet recruiting |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Not yet recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari) Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Fondazione del Piemonte per l'Oncologia IRCCS Candiolo Coordinator of this site? Confirm its status | Candiolo | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico) Coordinator of this site? Confirm its status | Catania | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Ospedale di Circolo Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Not yet recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Not yet recruiting |
| Pratia Onkologia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo (Poznan) | Poland | Not yet recruiting |
| Mics Centrum Medyczne Torun Coordinator of this site? Confirm its status | Torun | Poland | Not yet recruiting |
| Johns Hopkins Asthma & Allergy Center Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| SSAK Partners Coordinator of this site? Confirm its status | Coral Springs | United States | Recruiting |
| CBCI, Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| Hackensack Meridian Health Coordinator of this site? Confirm its status | Hackensack | United States | Not yet recruiting |
| Penn State Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Indiana University Health Arnett, Inc. Coordinator of this site? Confirm its status | Lafayette | United States | Not yet recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
| Carol G Simon Cancer Center Coordinator of this site? Confirm its status | Morristown | United States | Not yet recruiting |
| David H. Koch Center for Cancer Care Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| UC Irvine Coordinator of this site? Confirm its status | Orange | United States | Not yet recruiting |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Montefiore Medical Center Prime Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.