Taking peoplePhase 3

IgPro20 for low antibody levels after CAR T-cell or T-cell redirecting cancer therapy

Tests IgPro20 in adults with blood cancers and weakened immunity after immune cell therapy.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where: Fredericton and Montreal, CanadaSee the 2 sites
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a B-cell blood cancer who had CAR T-cell or T-cell engager therapy and now have low antibody levels (secondary immune deficiency). Everyone receives IgPro20.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Confirmed B-cell blood cancer (multiple myeloma, chronic lymphocytic leukemia, non-Hodgkin lymphoma or B-ALL) with a partial or complete response to CAR T-cell or T-cell engager therapy
Earlier treatment: At least 2 months after an approved CAR T-cell therapy, or at least 1 month after starting an approved T-cell engager bispecific antibody therapy and expected to continue it
Biomarker or test result: Serum IgG level below 500 mg/dL if not already on immunoglobulin replacement. With ongoing immunoglobulin replacement, any IgG level is accepted.

Main reasons for not taking part

History of diseases for which immunoglobulin replacement may be given, such as primary immune deficiency, Guillain-Barré syndrome or solid organ transplant
Blood clot event within 6 months before screening
ECOG performance status above 1
Active infection affecting the whole body at screening
Taking prohibited therapies, including anti-infective treatments

Read by machine on 9 November 2026.

Where in Canada

Horizon Health NetworkFredericton, CanadaNot yet recruiting
McGill University Health Research InstituteMontreal, CanadaNot yet recruiting

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: CSL Behring
Trial code: NCT07648264 EU 2026-525626-38-00
Record updated: 14 October 2026
Original description: 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.Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: 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; 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; 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; Eastern Cooperative Oncology Group performance status > 1.
ClinicalTrials.gov NCT07648264 · EU CTIS 2026-525626-38-00