Recruiting
Phase 3

IgPro20

Sponsor:

CSL Behring

Code:

NCT07648264

Conditions

Secondary Immune Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IgPro20

Study Details

Brief summary:

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.

Conditions

Secondary Immune Deficiency

Study ID

NCT07648264

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Mar 13, 2029

Anticipated

Primary completion date

Mar 13, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. 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
2. 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:

1. CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria
2. MM based on International Myeloma Working Group response criteria
3. NHL based on Lugano Classification criteria
4. 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 Criteria:

  • 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.
  • History of thromboembolic event (TEE) within 6 months before Screening.
  • Eastern Cooperative Oncology Group performance status > 1.
  • Presence of any systemic active infection at Screening.
  • Participants on any prohibited therapies, including anti-infective treatments.
  • 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.
  • 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.

Study Design

Enrollment

63 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IgPro20

In the loading cohort, participants will receive a loading dose of IgPro20 subcutaneously (SC) once daily for five consecutive days during the first week (Initial Treatment Period), followed by SC infusion weekly dosing for a total treatment duration of 52 weeks.

In the maintenance-only cohort, participants will receive weekly doses of IgPro20 SC infusion for a total treatment duration of 52 weeks.

Interventions

IgPro20

IgPro20 infusion administered SC.

Primary outcome measure

  • Number of Serious Bacterial Infections (SBIs) per Participant [ Time Frame: Up to Month 12 ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

+16108784697clinicaltrials@cslbehring.com

Locations

SSAK Partners

Recruiting

Coral Springs, Florida, United States, 33065

American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

More Information

Sponsor

CSL Behring

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Hematologic Malignancies
  • B-cell acute lymphoblastic leukemia (B-ALL)
  • Multiple myeloma (MM)
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • Non-Hodgkin lymphomas (NHL)
  • T-cell engager bispecific antibody (TCE BsAb) therapy
  • Hypogammaglobulinemia
  • Lowered serum immunoglobulin levels

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-09-09.