A Phase 2 interventional study of 30-40 mL of INTERCEPT RBCs and ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs in Transfusion Reaction, Hemolytic, sponsored by Cerus Corporation. Not yet recruiting at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Cerus Corporation · Phase 2, Interventional, and Screening
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
This is a prospective, open-label, controlled Phase 2 study. Consented subjects will be screened for currently detectable or previously documented allogeneic, autologous, and INTERCEPT RBC-specific antibodies, assigned to a study arm, then receive a small volume transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs under careful clinical oversight for adverse events including evidence of hemolysis.
Subjects will have blood samples drawn pre-transfusion and over 90 days after transfusion (Days 0, 1, 7, 14, 30, 60, and 90) to detect evidence of primary or secondary immune responses to INTERCEPT RBCs (see Section 8.4.2), and to assess the in vivo post transfusion 24-hour recovery (PTR24) and survival assessed as the half-life [T50], predicted mean/median lifespan, and area-under-the-survival curve (AUC) of the transfused cells.
RBCs and plasma will be collected and stored frozen for further analysis. Specific studies will include gel card-based INTERCEPT RBC antibody screen assay and titer, AHG crossmatch using cells from INTERCEPT RBC units prepared for transfusion, as well as RBC flow cytometric analysis using an antibody specific for acridine to quantitate the proportion of circulating INTERCEPT RBCs and the acridine adduct surface density.
Clinical evidence of hemolysis will be evaluated using routine laboratory tests, including complete blood counts (CBC), chemistry tests and urinalysis.
Test and Control subjects may be recruited from other INTERCEPT RBC studies. Control subjects may be recruited from specific age groups (e.g., children, adults) with specific medical conditions that are known to impact RBC survival in vivo, particularly conditions that are shown to be present in Test subjects (e.g., sickle cell disease, thalassemia).
After an initial challenge dose of 30-40 ml total volume (appx 20 ml RBCs at 50-70% hematocrit), subjects may be consented and enrolled for second and third challenge doses after completion of all study requirements for the subject's prior dose as well as a 120-day minimum wash-out period since the previous study transfusion.
If a subject requires a therapeutic RBC transfusion, had no evidence of hemolysis with the previous challenge dose(s) and remains eligible for a subsequent challenge dose, they may be administered a challenge dose of one full unit volume. Prior to administering each full unit challenge dose, a Data Safety Monitoring Board (DSMB) must perform an interim safety analysis considering all available study data.
Subjects may receive up to three challenge doses of INTERCEPT RBCs.
56 studies on the registry are indexed under Transfusion Reaction; 12 are open to participants now.
This study's planned enrollment of 25 is below the median of 71 across 23 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Cerus Corporation is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test subjects will be selected from the pool of subjects who have documented antibodies to INTERCEPT RBC either naturally acquired (e.g., detected during a pre-transfusion enrollment screening process) or treatment-emergent following an INTERCEPT RBC transfusion. Eligible subjects may have been enrolled in either the Test or Control arms of prior studies; subjects whose randomization status is still blinded may also be enrolled in this study if they have completed the study requirements of the prior study and \>120 days have elapsed since exposure to a study RBC product.
Device: 30-40 mL of INTERCEPT RBCs · Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs
Control subjects will be identified by participating study sites as individuals with a history of allogeneic transfusion(s) without a history of or currently demonstrable INTERCEPT RBC antibodies.
Device: 30-40 mL of INTERCEPT RBCs · Device: ~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.
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.
Acute or delayed hemolytic transfusion reactions
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.
Time frame: 90 days
Clearance
Incidence of rapid clearance (complete clearance by Day 30) of INTERCEPT RBCs assessed by flow cytometry.
Time frame: 30 days
Increase in Antibody Titer
Incidence of ≥4-fold increase in titer of INTERCEPT RBC antibodies from baseline (≥2 doubling dilution increase in titer), indicative of a secondary immune response.
Time frame: 90 days
In vivo recovery and survival kinetics
In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies. In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies.
Time frame: 90 days
Immunoglobulin subclass of INTERCEPT RBC-bound antibodies
Presence of and immunoglobulin subclass of INTERCEPT RBC-bound antibodies assessed by flow cytometry.
Time frame: 90 days
RBC alloantibodies or autoantibodies
RBC alloantibodies or autoantibodies not specific to INTERCEPT RBCs that develop during the study period.
Time frame: 90 Days
Antibody Characterization
Characterization of INTERCEPT RBC antibodies before and after challenge transfusion including: titer, binding specificity, immunoglobulin class, immunoglobulin subtype, and monocyte monolayer assay test result.
Time frame: 90 Days
Characterization of membrane-bound acridine
Characterization of membrane-bound acridine (acridine molecules per RBC) over the lifespan of transfused INTERCEPT RBCs in the presence and absence of INTERCEPT RBC antibodies.
Time frame: 90 Days
Comparison of AHG Crossmatch and INTERCEPT RBC antibody indirect antiglobulin test
Percent positive/negative agreement between pre-transfusion AHG crossmatch and INTERCEPT RBC antibody indirect antiglobulin test results with undiluted as well as serially diluted subject plasma.
Time frame: Day 0
Proportion of subjects with Adverse Events (AEs)
Proportion of subjects with AEs (non-serious and serious) documented from the start of the study RBC transfusion up to 24 hours after transfusion of any INTERCEPT RBC challenge.
Time frame: 24 hours after transfusion
Proportion of subjects with related AEs
Proportion of subjects with possibly, probably, or definitely related adverse events (i.e., transfusion reactions \[TR\]) documented from the start of the study RBC transfusion until the end of Day 90 (+/- 7 days).
Time frame: 90 Days
Proportion of subjects with study transfusion related serious adverse events (SAEs)
Proportion of subjects with study transfusion possibly, probably, or definitely related SAEs documented from the start of the study RBC transfusion until the end of the 90-day (+/- 7 days) post-transfusion monitoring period.
Time frame: 90 Days
Start is estimated for Oct 2026; primary completion for Sep 2030, 47 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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