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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well IgPro20 prevents serious bacterial infections, how safe it is, and how the body processes it. It is for adults with weakened immune defenses after CAR T-cell therapy or T-cell–redirecting treatment for B-cell blood cancers.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older and give written consent to join.
- You have a confirmed B-cell blood cancer: multiple myeloma, chronic lymphocytic leukemia, non-Hodgkin lymphoma, or B-cell acute lymphoblastic leukemia.
- You received an approved CAR T-cell treatment at least 2 months before screening, or started an approved T-cell engager bispecific antibody treatment at least 1 month before screening and expect to continue it.
- Tests show that your cancer has partly or fully responded to that treatment.
- If you are receiving antibody replacement treatment, any IgG level is allowed. IgG is an antibody that helps fight infections.
- If you are not receiving antibody replacement treatment, your IgG level must be below 500 mg/dL. You must have gone more than 8 weeks without antibody treatment through a vein or more than 2 weeks without it under the skin, and not expect to receive it during screening.
Who can't join
- You have a history of certain other conditions that may need antibody replacement treatment, including an immune problem present from birth, certain nerve, muscle, blood, or blood vessel diseases, or an organ transplant or rejection.
- You had a blood clot within 6 months before screening.
- Your ability to do daily activities is limited beyond an ECOG score of 1, a rating of how active you can be.
- You have an active infection affecting your body at screening.
- You take a treatment the study does not allow, including certain medicines for infections.
- Your neutrophil count is below 1 × 10⁹/L. Neutrophils are white blood cells that fight infections. An exception may apply if your disease causes the low count and medicine raises it above this limit.
- You are in another study that tests a treatment. Exceptions may be allowed if joining both studies would not harm your safety or this study’s results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (17)
CA
- UC Irvine · Orange, CA 92868More trials in Orange
CO
- CBCI, Colorado Blood Cancer Institute · Denver, CO 80218More trials in Denver
FL
- SSAK Partners · Coral Springs, FL 33065More trials in Coral Springs
- Mayo Clinic - Jacksonville · Jacksonville, FL 32224More trials in Jacksonville
IN
- Indiana University Health Arnett, Inc. · Lafayette, IN 47904More trials in Lafayette
MD
- Johns Hopkins Asthma & Allergy Center · Baltimore, MD 21224More trials in Baltimore
- American Oncology Partners, PA dba The Center for Cancer and Blood Disorders · Bethesda, MD 20817More trials in Bethesda
NC
- Duke University · Durham, NC 27710More trials in Durham
NJ
- Hackensack Meridian Health · Hackensack, NJ 07601More trials in Hackensack
- Carol G Simon Cancer Center · Morristown, NJ 07960More trials in Morristown
NY
- David H. Koch Center for Cancer Care · New York, NY 10065More trials in New York
- Montefiore Medical Center PRIME · The Bronx, NY 10467More trials in The Bronx
OH
- University of Cincinnati Medical Center · Cincinnati, OH 45219More trials in Cincinnati
PA
- Penn State Hershey Medical Center · Hershey, PA 17033More trials in Hershey
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
WA
- Fred Hutchinson Cancer Research Center · Seattle, WA 98109More trials in Seattle
WI
- Medical College of Wisconsin · Milwaukee, WI 53226More trials in Milwaukee