Gladiolus Study

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This Phase 2 clinical research study is evaluating the safety and effectiveness of a once-daily oral investigational medicine that may improve anemia and reduce the need for red blood cell (RBC) transfusions among some patients who are chronically transfused. All participants enrolled in the study will receive the investigational medication.
We are currently enrolling individuals who meet the following criteria:*

  • Are 12 to 65 years of age
  • Have one of the following diagnoses:
  • SCD and receiving regular RBC transfusions to prevent stroke or recurrence of stroke (Cohort A)
  • Thalassemia and receiving regular RBC transfusions (Cohort B)
  • Thalassemia and not receiving regular RBC transfusions (Cohort C)

There are additional eligibility requirements, which the investigator will explain to you.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at patelj23 [at] chop.edu or 267-426-5602.

Eligibility & Criteria

IRB #:
21-018910
Official Title:
A Phase 2 Open-Label Study To Evaluate Safety And Clinical Activity Of FT-4202 In Patients With Thalassemia Or Sickle Cell Disease
Study Phase:
Phase II
Eligible Age Range:
12 - 65 Years
Gender:
All
Study Categories:

Visit Criteria

The total length of participation is up to 58 weeks, or just over one year. During this time, participants will attend approximately 14 study visits over three periods: the screening period, the study treatment period, and an end-of-study visit four weeks after the last dose of the investigational medication. Each person who qualifies will receive research study–related medical exams, laboratory tests, and the investigational medication at no cost.

If the study medication improves your symptoms and anemia, you may qualify to participate in an extension of the study, in which you will receive the study drug for an additional year.