AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
AB Science
Study ID
NCT05211570
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Acute Myeloid Leukemia Refractory
  • Acute Myeloid Leukemia, in Relapse
  • Myelodysplastic Syndrome Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • AB8939 — DRUG
    Intravenous injection (from an initial dose of 0.9 mg/m²)
  • Venetoclax — DRUG
    the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.

Study Details

The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.

Key Dates

Start date
Jun 1, 2022
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AB8939
    AB8939 administered as a single agent
  • Experimental: AB8939 plus Venetoclax
    AB8939 administered in combination with venetoclax

Primary Outcome Measure

Rate of dose limiting toxicity (DLT) [ Time Frame: Up to 56 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

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