Sickle Cell DiseasePhase 2BARKNCT07155031
Biotin-Acridine Red Cell Exchange Kinetics
A Phase 2 study testing Pathogen reduced red blood cells in people with Sickle Cell Disease, run by Cerus Corporation.
Trial summary
The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter referred to as INTERCEPT RBCs) in patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Pathogen reduced red blood cells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 15 Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- homozygous sickle cell disease (HbSS) or Hemoglobin S-β-thalassemia (HbSβ0) SCD
- Receiving RCE for ≥3 months prior to enrollment and scheduled to undergo at least 4 sequential RCE episodes during the period of enrollment in the study
Who cannot join
- Anticipated cessation of RBC transfusion therapy in the next ≤2 months
- Planned stem cell transplant or gene therapy in the next 6 months
- Delayed hemolytic transfusion reaction in the past 3 months
- History of hyperhemolysis syndrome at any time
- Consuming high-dose biotin or raw egg supplements
- Current pregnancy
- Antibody specific to INTERCEPT RBCs or biotinylated red blood cells (BioRBCs) at baseline
- Patients with RBC alloantibodies that make it difficult to provide antigen matched blood.
About this study
Official title: Kinetics of Pathogen Reduced Red Blood Cell Clearance in Subjects Undergoing Red Cell Exchange for Sickle Cell Disease
The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter referred to as INTERCEPT RBCs) in patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy, utilizing flow cytometry for biotin and acridine RBC surface markers.
Read the detailed description
This trial is designed as a prospective, Phase 2, non-randomized, open-label, single arm, single center study in at least five (5) patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy.
Subjects receiving routine care for SCD utilizing regular RCE therapy at Grady Memorial Healthcare will be approached by Emory investigators and asked to enroll in the trial. Interested subjects will complete an informed consent form (ICF) and undergo pre-study screening, including a test for the presence of naturally-occurring antibodies with specificity for INTERCEPT RBCs and for antibodies with specificity for biotin. Subjects with a positive screen for INTERCEPT RBC antibodies or for biotin antibodies will be excluded from the study. Investigators will screen the current pool of patients receiving RCE treatment at Grady Memorial Healthcare to identify at least five (5) subjects who meet the study's enrollment criteria.
Enrolled and consented subjects will receive a full unit of INTERCEPT RBCs following each of two sequential RCE episodes (RCE #1 and RCE #2). The INTERCEPT RBCs will be administered by simple transfusion immediately following the end of each RCE. During RCE #1 subjects will also receive two biotinylated aliquots (~7 ml each) of RBCs drawn from the full INTERCEPT RBC unit before and after the PR process. The volume of each transfused aliquot will be assessed by weighing the syringe before and after transfusion. Each aliquot will be labeled at different biotin concentrations: (6 or 18 μg) to allow differentiation by flow cytometry. Subjects will be followed through a total of 4 sequential RCE episodes. Subjects will receive a full unit of INTERCEPT RBCs following RCE #2, with no biotinylated aliquots. No additional INTERCEPT RBCs will be transfused during RCE #3 or RCE #4.
To measure RBC recovery and blood volume, subject blood samples will be collected at the following time points:
- RCEs #1 and #2
- Day 0: pre-RCE and at 15, 30, and 60 minutes post-RCE.
- Days 1, 2-4, 7
- Day 14 post-RCE #1 (no Day 14 sample after RCE #2).
- RCEs #3 and #4
- Day 0: Fifteen minutes to 1 hour before and after the completion of each RCE episode.
- Appx Day 180 (±15 days) End of Study
Subjects will be screened for treatment-emergent antibodies to INTERCEPT RBCs and to biotinylated RBCs at screening and on day 14 post-RCE #1, Day 7 post-RCE #2, prior to RCE #3 and RCE #4 and on Day 180 (±15 days) post-RCE #1.
Subject RBC samples will be frozen and batched for flow-cytometry analysis at Cerus Corporation. De-glycerolized previously frozen RBCs will be used flow cytometry assessments. The assay to detect biotin levels by flow cytometry will use avidin- Allophycocyanin (APC) labeling in combination with an anti-acridine antibody. Acridine levels on INTERCEPT RBCs will be detected by flow cytometry utilizing a monoclonal antibody specific to the acridine moiety found on INTERCEPT RBCs. The antibody signal will be resolved in the phycoerythrin (PE) channel. QuantiBRITE PE beads (QB-PE) will be used to generate quasi-quantitative data for acridine RBC surface antigen labelling.
Subjects will be monitored closely during the blood transfusion procedure by staff trained to detect adverse events with transfusion. Laboratory monitoring for events of special interest will occur for 4 weeks (for hemolytic transfusion reactions) after RCE#1.
- Conditions
- Sickle Cell Disease
- Being tested
- Pathogen reduced red blood cells
- Keywords
- pathogen reduction, sickle cell disease, red cell exchange, biotin
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen reduced red blood cellsDevice
Also called Biotin
pathogen reduced red blood cells with biotin labeled aliquots will be transfused as part of routine care red cell exchange procedures
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All subjects enrolled in CLI00185 will participate in the intervention arm which includes transfusion of a single pathogen reduced red blood cell unit in conjunction with two sequential red cell exchange episodes (as prescribed by subjects attending physician). Subjects will also receive aliquots of biotin labeled red blood cells during the first of the two red cell exchange episodes. Receives: Device: Pathogen reduced red blood cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery
The volume of distribution and 24-hour post transfusion recovery (PTR24) of the INTERCEPT RBC units
Measured: 24 hour
Correlation between the biotin and acridine markers
Correlation between the biotin and acridine markers for determining the number of circulating INTERCEPT RBCs
Measured: 6 months
Survival
Comparison of Pre-PR and INTERCEPT RBC PTR24, and survival over the duration of the study with intervening RCE procedures
Measured: 6 months
Acridine loss
Kinetics of acridine loss from the INTERCEPT RBC surface
Measured: 6 months
Secondary outcomes (2)
Adverse Events
All subjects will be monitored for adverse events and transfusion reactions according to standard operating procedures at the RCE site
Measured: 6 months
Treatment emergent antibodies
Safety assessments will also include screening for treatment emergent antibodies with specificity for INTERCEPT RBCs and for biotinylated RBCs on day 14 post-RCEs #1, Day 7 post-RCE #2, prior to RCE #3 and RCE #4 and on Day 180 (±15 days) post-RCE #1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Why it stopped: This study has been suspended due to a lack of funding. The protocol will be reconsidered within the next 6-12 months if/as funding becomes available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Phase 2, non-randomized, open-label, single arm, single center study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155031
- Sponsor's protocol ID
- CLI 00185
- Other IDs
- 75A50124C00046
- Acronym
- BARK
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Pathogen Reduced Red Blood Cell Clearance in Subjects Undergoing Red Cell Exchange for Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07155031
- Acronym / sponsor ID
- BARK / CLI 00185
- Conditions
- Sickle Cell Disease
- Keywords
- pathogen reduction, sickle cell disease, red cell exchange, biotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been suspended due to a lack of funding. The protocol will be reconsidered within the next 6-12 months if/as funding becomes available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter referred to as INTERCEPT RBCs) in patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy, utilizing flow cytometry for biotin and acridine RBC surface markers.
Detailed description
This trial is designed as a prospective, Phase 2, non-randomized, open-label, single arm, single center study in at least five (5) patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy.
Subjects receiving routine care for SCD utilizing regular RCE therapy at Grady Memorial Healthcare will be approached by Emory investigators and asked to enroll in the trial. Interested subjects will complete an informed consent form (ICF) and undergo pre-study screening, including a test for the presence of naturally-occurring antibodies with specificity for INTERCEPT RBCs and for antibodies with specificity for biotin. Subjects with a positive screen for INTERCEPT RBC antibodies or for biotin antibodies will be excluded from the study. Investigators will screen the current pool of patients receiving RCE treatment at Grady Memorial Healthcare to identify at least five (5) subjects who meet the study's enrollment criteria.
Enrolled and consented subjects will receive a full unit of INTERCEPT RBCs following each of two sequential RCE episodes (RCE #1 and RCE #2). The INTERCEPT RBCs will be administered by simple transfusion immediately following the end of each RCE. During RCE #1 subjects will also receive two biotinylated aliquots (~7 ml each) of RBCs drawn from the full INTERCEPT RBC unit before and after the PR process. The volume of each transfused aliquot will be assessed by weighing the syringe before and after transfusion. Each aliquot will be labeled at different biotin concentrations: (6 or 18 μg) to allow differentiation by flow cytometry. Subjects will be followed through a total of 4 sequential RCE episodes. Subjects will receive a full unit of INTERCEPT RBCs following RCE #2, with no biotinylated aliquots. No additional INTERCEPT RBCs will be transfused during RCE #3 or RCE #4.
To measure RBC recovery and blood volume, subject blood samples will be collected at the following time points:
- RCEs #1 and #2
- Day 0: pre-RCE and at 15, 30, and 60 minutes post-RCE.
- Days 1, 2-4, 7
- Day 14 post-RCE #1 (no Day 14 sample after RCE #2).
- RCEs #3 and #4
- Day 0: Fifteen minutes to 1 hour before and after the completion of each RCE episode.
- Appx Day 180 (±15 days) End of Study
Subjects will be screened for treatment-emergent antibodies to INTERCEPT RBCs and to biotinylated RBCs at screening and on day 14 post-RCE #1, Day 7 post-RCE #2, prior to RCE #3 and RCE #4 and on Day 180 (±15 days) post-RCE #1.
Subject RBC samples will be frozen and batched for flow-cytometry analysis at Cerus Corporation. De-glycerolized previously frozen RBCs will be used flow cytometry assessments. The assay to detect biotin levels by flow cytometry will use avidin- Allophycocyanin (APC) labeling in combination with an anti-acridine antibody. Acridine levels on INTERCEPT RBCs will be detected by flow cytometry utilizing a monoclonal antibody specific to the acridine moiety found on INTERCEPT RBCs. The antibody signal will be resolved in the phycoerythrin (PE) channel. QuantiBRITE PE beads (QB-PE) will be used to generate quasi-quantitative data for acridine RBC surface antigen labelling.
Subjects will be monitored closely during the blood transfusion procedure by staff trained to detect adverse events with transfusion. Laboratory monitoring for events of special interest will occur for 4 weeks (for hemolytic transfusion reactions) after RCE#1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Phase 2, non-randomized, open-label, single arm, single center study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Pathogen reduced red blood cellsAll subjects enrolled in CLI00185 will participate in the intervention arm which includes transfusion of a single pathogen reduced red blood cell unit in conjunction with two sequential red cell exchange episodes (as prescribed by subjects attending physician). Subjects will also receive aliquots of biotin labeled red blood cells during the first of the two red cell exchange episodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- homozygous sickle cell disease (HbSS) or Hemoglobin S-β-thalassemia (HbSβ0) SCD
- Receiving RCE for ≥3 months prior to enrollment and scheduled to undergo at least 4 sequential RCE episodes during the period of enrollment in the study
Key exclusion criteria (8 listed)
- Anticipated cessation of RBC transfusion therapy in the next ≤2 months
- Planned stem cell transplant or gene therapy in the next 6 months
- Delayed hemolytic transfusion reaction in the past 3 months
- History of hyperhemolysis syndrome at any time
- Consuming high-dose biotin or raw egg supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen reduced red blood cellsAlso: Biotinpathogen reduced red blood cells with biotin labeled aliquots will be transfused as part of routine care red cell exchange procedures | Device | Intervention Arm |
Primary outcome
Recovery
Time frame: 24 hour
The volume of distribution and 24-hour post transfusion recovery (PTR24) of the INTERCEPT RBC units
Correlation between the biotin and acridine markers
Time frame: 6 months
Correlation between the biotin and acridine markers for determining the number of circulating INTERCEPT RBCs
Survival
Time frame: 6 months
Comparison of Pre-PR and INTERCEPT RBC PTR24, and survival over the duration of the study with intervening RCE procedures
Acridine loss
Time frame: 6 months
Kinetics of acridine loss from the INTERCEPT RBC surface
2 secondary outcomes
Adverse Events
Time frame: 6 months
Treatment emergent antibodies
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pathogen reduced red blood cells in people with Sickle Cell Disease, run by Cerus Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery (time frame: 24 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.