Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525626-38-00 | Registry Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological | IgPro20 infusion administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Bacterial Infections (SBIs) per Participant | The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infections per Participant | Up to Month 12 | |
| Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant | As per CTCAE, Grade 3 is defined as Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to adverse event. Infections of CTCAE Grade 3 or worse will be reported. |
Not provided
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:
Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening:
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | +16108784697 | clinicaltrials@cslbehring.com |
Not provided
Not provided
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Not provided
Not provided
This is single group open-label study.
Not provided
Not provided
This is open-label study.
Not provided
| Up to Month 12 |
| Number of Days Hospitalized due to Infections | Up to Month 12 |
| Number of Days With Anti-infectives Use | Up to Month 12 |
| Number of Infection-related Deaths and Complications | Up to Month 12 |
| Number of Infection-related Requirement for Intravenous (IV) Therapy | Up to Month 12 |
| Number of Infection-related Requirement for Hospitalization per Participant | Up to Month 12 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Infusion Site Reaction and Other Local Reactions | In this study, thromboembolic events are treated as AESIs. The following 3 narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) queries are used for TEE evaluation:
| Up to Month 12 |
| Trough Concentrations of Serum IgG | Up to Week 56 |
| Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t]) | Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20) |
| Maximal Serum Concentration (Cmax) of IgG | Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20) |
| Time to Maximal Serum Concentration (Tmax) of IgG | Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20) |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D002051 | Burkitt Lymphoma |
| D009101 | Multiple Myeloma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000361 | Agammaglobulinemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007153 | Immunologic Deficiency Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| C558471 | Hizentra |
| D005719 | gamma-Globulins |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided