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Anti-tumor antibiotic

REM-422 for Acute Myelogenous Leukemia

Phase 1

Waitlist Available

Research Sponsored by Remix Therapeutics

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

Study Summary

This trial aims to test the safety and effectiveness of REM-422, a drug that targets MYB mRNA, in people with a type of blood disorder called Higher Risk MDS and a type of leukemia

Who is the study for?

This trial is for individuals with higher risk Myelodysplastic Syndrome (MDS) or relapsed/refractory Acute Myeloid Leukemia (AML). Specific eligibility criteria are not provided, but typically include factors like age, disease stage, and overall health.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of REM-422, a new treatment designed to target MYB mRNA in patients with high-risk MDS or AML that has come back or hasn't responded to other treatments.See study design

What are the potential side effects?

Potential side effects of REM-422 are not detailed here. However, as an investigational drug targeting mRNA processes within cells, common side effects may include fatigue, nausea, fever, and potential blood-related issues.

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

Frequency and severity of Treatment Emergent Adverse Events (TEAEs)

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

AML: Duration of CR

AML: Duration of CRh

AML: Duration of response (DOR)

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: REM-422Experimental Treatment1 Intervention

Dose Escalation: Participants will receive escalating doses of REM-422 to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)-422, oral capsule administered once daily Dose Expansion: Participants will receive REM-422 at the identified RP2D Treatment will continue until disease progression, therapy intolerance, or participant withdrawal Safety evaluation will continue until 30 days of last administration of REM-422

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Remix TherapeuticsLead Sponsor

1 Previous Clinical Trials

65 Total Patients Enrolled

Christopher Bowden, MDStudy ChairRemix Therapeutics

1 Previous Clinical Trials

65 Total Patients Enrolled

Frequently Asked Questions

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

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"This trial is conducted at esteemed institutions like City of Hope in Duarte, California; Mayo Clinic in Jacksonville, Florida; Memorial Sloan Kettering in New york, New York; and an additional 4 sites."

Answered by AI

Is the current investigation open for participant enrollment?

"The clinical trial, initially shared on 3/15/2024 and most recently revised on 2/29/2024, is no longer open for participant recruitment as indicated by information available on clinicaltrials.gov. Nonetheless, there are currently 2894 alternative studies actively seeking participants."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The primary aim of this examination is to scrutinize the frequency and severity of Treatment Emergent Adverse Events (TEAEs) over a 24-month period, assessed at the conclusion of each 28-day cycle. Additionally, secondary objectives encompass determining REM-422's pharmacokinetic profile by measuring maximal concentration (Cmax), minimal concentration (Cmin), and time to peak drug concentration (Tmax)."

Answered by AI

What are the potential risks associated with REM-422 for individuals undergoing treatment?

"The safety of REM-422 is rated at 1 by our team due to the early Phase 1 trial stage, indicating minimal data available on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of REM-422 in Patients With AML or Higher Risk MDS

2024. "Study of REM-422 in Patients With AML or Higher Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06297941.