IMG-7289 for Blood Cell Disorders

Overseen By Karin Suarez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Terrence J Bradley, MD

Must not be taking: MAOIs, Romiplostim

Disqualifiers: Pregnancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the hematologic effects of IMG-7289 therapy in ET and PV patients who require platelet, White Blood Cell (WBC) or Red Blood Cell (RBC) control, and have failed at least one standard therapy.

Do I need to stop my current medications to join the trial?

Yes, you must stop your current therapy for the condition being studied at least 2 weeks before starting the trial drug (4 weeks for interferon).

Research Team

Terrence Bradley, MD

Principal Investigator

University of Miami

Eligibility Criteria

Adults diagnosed with Essential Thrombocythemia or Polycythemia Vera who haven't responded well to at least one standard treatment. Participants must have certain blood cell counts, agree to contraception, and be able to swallow capsules. Excluded are those with poor physical condition scores, pregnancy/breastfeeding plans, non-US residency, history of splenectomy, unresolved toxicities from past treatments, uncontrolled infections including HIV/hepatitis or bleeding risks.

Inclusion Criteria

I am willing to undergo blood tests, spleen measurements, and bone marrow exams for the study.

I have been diagnosed with Essential Thrombocythemia or Polycythemia Vera.

I agree not to father a child or donate sperm for a month after my last dose.

Exclusion Criteria

I do not have any ongoing infections that aren't responding to treatment.

I have a higher risk of bleeding due to blood test results or a history of bleeding disorders.

I am not allergic to IMG-7289, LSD1 inhibitors, or similar drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Pilot Treatment

Initial pilot period where 8 participants receive oral daily dose of IMG-7289 for 24 weeks

24 weeks

Extended Treatment

Second stage group where an additional 16 participants receive IMG-7289 for over 2 years

Over 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• IMG-7289

Trial Overview The trial is testing IMG-7289's ability to control platelet, WBC or RBC levels in patients with ET or PV who've had inadequate responses to previous therapies. It involves regular monitoring through blood draws and bone marrow evaluations.

Participant Groups

Group I: IMG-7289 in ET and PV Patients Experimental Treatment 1 Intervention

Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered: * The initial pilot period will enroll 8 participants to receive oral daily dose of IMG-7829 for 24 weeks, iteratively as long as there is clinical benefit in the absence of excess toxicity. * The second stage group will enroll an additional 16 participants to receive IMG-7829 for over 2 years, iteratively as long as there is clinical benefit in the absence of toxicity.

Who Is Running the Clinical Trial?

Terrence J Bradley, MD

Lead Sponsor

Trials

2

Recruited

20+

Imago BioSciences,Inc.

Industry Sponsor

Trials

10

Recruited

380+

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Industry Sponsor

Trials

10

Recruited

380+