Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs

NCT07152379 · tracked via the Priya Life Science USA tracker

Sponsor

Cerus Corporation

Phase

Phase 2

Started

2026-10-10

Last updated

2026-10-14

Condition(s) studied

Transfusion Reaction, Hemolytic

Investigational drug(s) / intervention(s)

30-40 mL of INTERCEPT RBCs~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs

30-40 mL of INTERCEPT RBCs: Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.

~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs: Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or \~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.

Study summary

This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and/or evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).

The study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs

Eligibility

Sex

ALL

Min age

4 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB). * Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC. * Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs. * History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated). * \>120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion. * Signed and dated informed consent form Exclusion Criteria: * Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period. * Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study. * Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion. * Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity/mortality due to hemolysis or the medical management of acute hemolysis. * Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins) * History of or development of a drug-associated RBC antibody not associated with INTERCEPT RBCs. * Congenital or acquired immunodeficiency judged by the Investigator to potentially impact the humoral immune response. * Immunosuppressive therapy within 1 month prior to enrollment or during the study period, including steroids and intravenous immunoglobulin. * Current or historical RBC alloantibodies that are judged by the Investigator to prevent selection of antigen-negative RBCs for transfusion. * History of immunoglobulin A (IgA) deficiency, severe allergic reaction to blood product(s), or clinical requirement to receive washed cellular products. * History of warm autoantibody with hemolysis. * Subjects who are pregnant, or biologically able to become pregnant and unwilling to remain on medically accepted contraception during this study.

Primary outcome measure(s)

Acute or delayed hemolytic transfusion reactions — 90 days
Incidence of acute or delayed hemolytic transfusion reactions (AHTR or DHTR) attributed to the study INTERCEPT RBC transfusion, based upon clinical and/or laboratory findings, using Centers for Disease Control (CDC) Hemovigilance criteria.
Clearance — 30 days
Incidence of rapid clearance (complete clearance by Day 30) of INTERCEPT RBCs assessed by flow cytometry.

Trial sites (1)

Facility	City	Region	Status
University of Colorado Hospital Anschutz	Aurora	Colorado

More Cerus Corporation trials in the USA

Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage Enrolling by invitation

A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1 Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07152379 on ClinicalTrials.gov ↗ ← All trials in the USA