Recruiting
Phase 2

INTERCEPT RBCs

Sponsor:

Cerus Corporation

Code:

NCT07015437

Conditions

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

INTERCEPT Blood System for RBCs

Infusion of autologous radiolabeled RBCs

Study Details

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

Study ID

NCT07015437

Start date

Sep 19, 2025

Status verified date

Sep, 2026

Completion date

Feb 13, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

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.

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

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.

Interventions

INTERCEPT Blood System for RBCs

RBCs treated with the INTERCEPT Blood System for RBCs

Infusion of autologous radiolabeled RBCs

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

Primary outcome measure

  • The percentage of infused 35-day-old autologous 51Cr-labeled Test/INTERCEPT or Control RBCs remaining in circulation 24 hours post-infusion [ Time Frame: Pre-transfusion and 5, 7.5, 10, 12.5, 15, 20, and 30 minutes and at 24 hours after infusion ]

Central Contacts and Locations

Central contacts

Margaret Hennig, Ph.D.

925-288-6178mhennig@cerus.com

Locations

American Red Cross Research Laboratory

Recruiting

Norfolk, Virginia, United States, 23510

More Information

Sponsor

Cerus Corporation

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Cerus Corporation on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.