A Study of Rebecsinib for Patients With Relapsed/Refractory Secondary Acute Myeloid Leukemia or High Risk Myelofibrosis

Part of paid clinical trials in Duarte, California.

Sponsor
Aspera Biomedicines, Inc.
Study ID
NCT07250646
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelofibrosis
  • Secondary AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rebecsinib — DRUG
    Rebecsinib is administered by intravenous infusion on Days 1, 4, 8, and 11 of the 28 day cycle. Doses to be tested are 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 8.0 mg/kg based in ideal body weight (IBW).

Study Details

The purpose of this study is to test the safest and most effective dose of a new investigational drug, rebecsinib. Participants in this study will have either Secondary Acute Myeloid Leukemia (sAML) that has either returned (relapsed) or not responded to treatment (refractory) or have higher risk Myelofibrosis (MF). Participants will receive a study drug infusion on Day 1, Day 4, Day 8 and Day 11 of each 28-day cycle for a total of 6 cycles.

Key Dates

First listed
Nov 26, 2025
Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Primary Outcome Measure

Determine the Maximum Tolerated Dose [ Time Frame: From first dose through 28 days after initial dose for dose all finding cohorts, approximately 2 years. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope CenterDuarteCalifornia91010
Haris Ali, MD
[email protected]
626-218-2405
Farrah Farshidfard
[email protected]
626-218-2918
Haris Ali, MD (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterSan DiegoCalifornia92093
Rebecca Jimenez, MD, PhD
[email protected]
858-822-5377
Oliva Nolan
[email protected]
858-246-5794
James Mangan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Center· Duarte, CAUC San Diego Moores Cancer Center· San Diego, CA

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