Nerofe for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1

Recruiting

Research Sponsored by Immune System Key Ltd

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.

Pre-treatment bone marrow staining must demonstrate expression of the ST2 receptor by IHC (low or high expression is allowed).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NEROFE, a new drug given through an IV, on patients with certain blood cancers to find a safe dose and see if it helps control their cancer.

Who is the study for?

Adults with advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) who haven't responded to standard treatments can join. They must have a certain level of disease risk, be in fair health, and their organs need to function well. People with severe liver or kidney issues, very high white blood cell counts without control measures, or poor venous access for blood sampling cannot participate.

What is being tested?

The trial is testing NEROFE, a new hormone-peptide treatment for MDS and AML. It's given intravenously three times weekly based on body size. The study aims to find the safest dose that works best (RP2D).

What are the potential side effects?

Possible side effects of NEROFE are not detailed here but may include reactions related to IV administration and impacts on organ functions due to its novel hormonal nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My bone marrow shows ST2 receptor presence.

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My kidney function, measured by creatinine or eGFR, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at every cycle on day 1, day 3, day 8, day 10, day 12, d15, day 17, day 19, day 22, day 24, day 26 and day 28 (cycle length is 28 days), and at end of treatment visit, through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients

Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.

Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients

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