IMG-7289 for Blood Cell Disorders

Recruiting in Palo Alto (17 mi)

Overseen byTerrence Bradley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Terrence J Bradley, MD

No Placebo Group

Prior Safety Data

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.

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 18 years old or older.

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.

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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.

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Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: IMG-7289 in ET and PV PatientsExperimental Treatment1 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.