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Monoclonal Antibodies

LN Cohort for Microscopic Polyangiitis (GLEAM Trial)

Phase 1

Recruiting

Research Sponsored by Sana Biotechnology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

GLEAM Trial Summary

This trial is testing a new drug called SC291 to see if it is safe and well-tolerated in people with severe autoimmune diseases. The study will also look at how the drug affects the body

Who is the study for?

This trial is for adults aged 18-75 with severe autoimmune diseases like Wegener's Granulomatosis, Lupus, and Vasculitis. Participants must have a specific diagnosis based on EULAR/ACR criteria and not responded to at least two prior treatments. People with CNS lupus manifestations, anti-phospholipid antibody syndrome, or previous CD19-directed cell therapy are excluded.Check my eligibility

What is being tested?

The study is testing SC291's safety and effectiveness in treating severe refractory B-cell mediated autoimmune diseases. It will look at how the body responds to the drug, its side effects, and any signs of improvement in disease symptoms.See study design

What are the potential side effects?

While specific side effects of SC291 are not listed here as it's an early-phase trial assessing safety and tolerability, common side effects may include reactions at the injection site, fatigue, headache, nausea or potential immune system-related responses.

GLEAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate safety and tolerability of SC291

Secondary outcome measures

Evaluate cellular kinetics and persistence of SC291

Evaluate preliminary clinical response to SC291

Evaluate preliminary clinical response to SC291 (AAV Cohort)

+3 more

GLEAM Trial Design

3Treatment groups

Experimental Treatment

Group I: LN CohortExperimental Treatment1 Intervention

SC291 with lymphodepleting therapy

Group II: ERL CohortExperimental Treatment1 Intervention

SC291 with lymphodepleting therapy

Group III: AAV CohortExperimental Treatment1 Intervention

SC291 with lymphodepleting therapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sana BiotechnologyLead Sponsor

3 Previous Clinical Trials

94 Total Patients Enrolled

Paul BrunettaStudy DirectorSana Biotechnology, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research investigation?

"Indeed, information available on clinicaltrials.gov highlights the ongoing recruitment for this particular trial. The initial posting of this clinical study was on April 1st, 2024, with the most recent update recorded on March 28th, 2024. Enrollment aims to include a total of 36 participants at a single designated site."

Answered by AI

Does this medical study allow participation for individuals older than 45 years?

"Patients seeking to enroll in this clinical investigation must be at least 18 years old and no more than 75 years of age."

Answered by AI

Are there any ongoing opportunities for individuals to participate in this research study?

"Indeed, as per the details on clinicaltrials.gov, this particular research endeavor is actively enrolling eligible participants. The trial was first made public on April 1st, 2024 and last revised on March 28th of the same year. It aims to recruit a total of 36 individuals from one designated site."

Answered by AI

Is it possible for me to participate in this research study?

"Interested individuals must be between 18 and 75 years old with microscopic polyangiitis. Eligibility requires a confirmed SLE diagnosis according to the 2019 EULAR/ACR criteria, LN class III or IV as per the 2018 ISN/RPS guidelines, unresponsiveness to at least two prior treatments, and meeting the adult SLE classification criteria from EULAR/ACR. Additionally, for those in the AAV Cohort, a GPA or MPA diagnosis based on the 2022 ACR/EULAR criteria is mandatory."

Answered by AI

What is the safety profile of LN Cohort in patients?

"The safety rating for LN Cohort is 1 as per our team at Power, reflecting the early Phase 1 nature of the trial and its limited data on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

2024. "Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06294236.

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