ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07648264.
- What is being tested: IgPro20 (immunoglobulin replacement therapy) efficacy, safety, and pharmacokinetics in adults with secondary immune deficiencies resulting from B-cell targeting CAR T-cell and T-cell redirecting therapies used to treat hematologic malignancies.
- Patient eligibility overview: Adults with hematologic malignancies who have received B-cell targeting CAR T-cell therapies or T-cell redirecting therapies (such as bispecific antibodies) and have subsequently developed secondary immune deficiencies requiring immunoglobulin support.
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What This Trial Is Studying
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 (
Eligibility Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.