CB-5339 for Myelodysplastic Syndrome

Weill Cornel Medical Center, New York, NY
Myelodysplastic Syndrome+1 More ConditionsCB-5339 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new drug for people with certain types of leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia (AML) in Relapse

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 28 Days

28 Days
Define the MTD and/or RP2D and schedule for CB-5339
Therapeutic procedure
Day 4
Accumulation ratio
Area under the plasma concentration time curve (AUC0-t)
Elimination half-life (t½)
Peak plasma concentration (Cmax)
Time to reach peak plasma concentration (Tmax)
Day 28
Antitumor effects

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

CB-5339
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: CB-5339 · No Placebo Group · Phase 1

CB-5339
Drug
Experimental Group · 1 Intervention: CB-5339 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

Who is running the clinical trial?

Cleave Therapeutics, Inc.Lead Sponsor
Scott HarrisStudy ChairCleave Therapeutics, Inc.

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

To what degree is CB-5339 hazardous to human health?

"Our experts at Power rated CB-5339 a 1 on the safety scale, due to this being an initial trial with limited evidence in terms of efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Is enrollment still open for the trial?

"Clinicaltrials.gov has confirmed that this trial is actively recruiting participants; the initial posting was on June 8th 2020, with a recent edit occurring on July 27th 2022." - Anonymous Online Contributor

Unverified Answer

In what locations are this trial's efforts being conducted?

"At present, 8 medical centres are recruiting patients for this clinical trial. These locales span from Cleveland to Greenville and various other spots in-between; it is advisable to choose the nearest site of enrolment so as to abate any travel hardships." - Anonymous Online Contributor

Unverified Answer

How many individuals are participating in the experiment?

"To launch the trial, 60 eligible individuals are needed. Cleave Therapeutics, Inc., is managing this study across multiple sites including Cleveland Clinic and Case Comprehensive Cancer Center in Ohio as well as Weill Cornel Medical Center in New York City." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.