Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malig… (NCT07648264) | Clinical Trial Compass
Not Yet RecruitingPhase 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
63 participantsStarted 2026-07-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people with secondary immune deficiency caused by CAR-T or T-cell redirecting therapies for blood cancers — does my situation and treatment history actually match that profile, and is it worth discussing whether I'd be a realistic candidate?
2The trial is measuring serious bacterial infections, which suggests one of the main concerns is whether IgPro20 can reduce those infections in people whose immune systems have been weakened by these therapies — how does my current infection risk compare to what this study is designed to address?
3Since this is a Phase 3 single-arm study, meaning everyone gets the treatment and there's no placebo group, what does that tell us about how much is already known about IgPro20's safety, and are there any risks I should be aware of before considering it?
4The trial isn't recruiting yet — how long might it realistically be before it opens, and in the meantime, are there standard immunoglobulin replacement options that could protect me from serious infections now?
5Because this is a single-arm study focused on a very specific patient population, would my doctor consider this the right path for me, or are there other approved treatments or trials that might be a better fit given where I am in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Serious Bacterial Infections (SBIs) per Participant