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

NCT07015437 | Recruiting Phase 2 FDA Device

• 1 other identifier: CLI 00182
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.

Conditions

Healthy Subjects

Keywords

INTERCEPT; Red Blood Cells; RBC; Pathogen Inactivation; Pathogen reduction; Cerus; Survival; Radiolabel; Autologous; Recovery

Outcome Measures

Primary Outcomes (1)

• The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion

  The 24-hour recovery will be calculated using the subject's blood volume derived from infusion of 99mTc-labeled fresh RBCs.

  Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion

Secondary Outcomes (3)

• . The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion

  Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion

• . The number of days 51Cr-labeled Test/INTERCEPT or Control RBCs remain in circulation up to post-infusion

  Over 35 days post infusion

• Hemolysis (<1%)

  35 days

Other Outcomes (1)

• Adverse Events

  90 days

Study Arms (2)

Test RBCs will be prepared with the INTERCEPT Blood System for RBCs

EXPERIMENTAL

One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Test treatment arm for preparation of the Test RBCs. The Test RBCs will be prepared with the INTERCEPT Blood System for RBCs with AS-1, within 24 hours or 25 to 48 hours post collection (depending on randomization assignment) and stored at 1°C to 6°C for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 autologous 51Cr radiolabeled Test RBCs.

Device: INTERCEPT Blood System for RBCs; Other: Infusion of autologous radiolabeled RBCs

Control RBC components will be prepared according to the site standard operating procedures

EXPERIMENTAL

One unit of WB (500 ±50 mL) will be collected from subjects randomized to the Control treatment arm for preparation of the Control RBCs in AS-1. The Control RBC components will be prepared and stored at 1°C to 6°C, according to the site standard operating procedures, for 35 days. On Day 35 the subject will receive a single intravenous infusion of approximately 10 to 30 mL of Day 35 51Cr autologous radiolabeled Control RBCs.

Other: Infusion of autologous radiolabeled RBCs

Interventions

INTERCEPT Blood System for RBCs DEVICE

RBCs treated with the INTERCEPT Blood System for RBCs

Test RBCs will be prepared with the INTERCEPT Blood System for RBCs

Infusion of autologous radiolabeled RBCs OTHER

Subject will receive a single intravenous infusion of approximately 10 to 30 mL of autologous Day 35 51Cr radiolabeled RBCs and fresh 99mTc RBCs.

Control RBC components will be prepared according to the site standard operating procedures; Test RBCs will be prepared with the INTERCEPT Blood System for RBCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
• Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:
• Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
• Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
• Signed and dated informed consent form

You may not qualify if:

• History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
• History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
• Positive DAT or IAT at study entry
• Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
• Treatment with any medication known to affect RBC viability
• Pregnant or nursing females
• Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days
• Less than three months from receiving an infusion of a radiolabeled blood component.
• Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.
• Non study blood component donation throughout the study
• Preexisting antibody specific to INTERCEPT RBCs
• History of known hypersensitivity to chromium or technetium

Sponsors & Collaborators

• Cerus Corporation: lead

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

American Red Cross Research Laboratory

Norfolk, Virginia, 23510, United States

RECRUITING

MeSH Terms

Interventions

Erythrocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Margaret Hennig, Ph.D.

CONTACT

925-288-6178; mhennig@cerus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects are blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 11, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (2)