NCT05393999

SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations

The SABRE Trial: A Single-arm Prospective Study Measuring Safety, Tolerability and Pharmacokinetics of Two SARS-CoV-2 Neutralising Antibodies (C135-LS and C144-LS) Amongst High-risk Special Populations of Vaccine Non-responders.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Imperial College Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The SABRE study is a single-arm prospective study measuring safety, tolerability and pharmacokinetics of two SARS-CoV-2 neutralising antibodies (BMS-986414 and BMS-986413) amongst high-risk special populations of vaccine non-responders. The aim is to test the hypothesis that for individuals who fail to mount a measurable immune response to a routinely offered SARS-CoV-2 prophylactic vaccine or for those who are not able to receive such a vaccine (for example those receiving a bone marrow transplant or starting chemotherapy treatment), the receipt of subcutaneous injection of two long-acting neutralising antibodies BMS-986414 and BMS-986413 will confer durable high titres and subsequent immunological protection against SARS-CoV-2 infection.120 eligible participants will be enrolled and followed up for 48 weeks after the one-time dosing visit. Primary inclusion criteria are patients age 18 years and older and either 1) have received two doses of a routine NHS standard of care SARS-Cov-2 vaccine and do not have detectable serum SARS-CoV-2 anti-spike antibodies in routine NHS assays more than two weeks post-vaccination, or do not have protective levels of antibody or 2) be ineligible to receive a SARS-CoV-2 prophylactic vaccine. This could be because they need to commence immediate systemic chemotherapy or receive bone marrow and therefore the requirement to initiate profound immune suppression. Primary objectives are to determine the safety, tolerability and detectable SARS-CoV-2 antibody by specific PPD assay in serum at 12 weeks after enrolment.

Conditions

• SARS-CoV2 Infection
• SARS-CoV-2 Acute Respiratory Disease
• Myeloma
• Leukemia
• Lymphoma
• Immune Thrombocytopenia
• Thrombotic Thrombocytopenic Purpura (TTP)

Interventions

Type	Name	Description
BIOLOGICAL	BMS-986414	Broadly neutralising antibodies BMS-986414
BIOLOGICAL	BMS-986413	Broadly neutralising antibodies BMS-986413

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2022-05-27
• Last updated: 2023-04-24

Locations

1 site across 1 country: United Kingdom