REM-422 for Acute Myeloid Leukemia and Higher Risk MDS

Phase 1

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and severity of Treatment Emergent Adverse Events (TEAEs)

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

Secondary study objectives

AML: Duration of CR

AML: Duration of CRh

AML: Duration of response (DOR)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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