NCT05716009View on ClinicalTrials.gov

Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 20, 2023

Primary Completion Date

December 25, 2027

Study Completion Date

December 25, 2028

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Dose Escalation -tagraxofusp-erzs

Sequential dose levels of tagraxofusp-erzs dependent on patient response. Fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles.

DRUG

Dose Expansion at RP2D -tagraxofusp-erzs

Following the dose escalation portion, the expansion dose and schedule (RP2D) will be determined. Patients will continue to receive fixed doses of gemtuzumab ozogamicin 3mg/m2/day on days 1, 4, and 7 of cycle 1 then on Day 1 or all subsequent cycles for a total of 3 cycles.

Trial Locations (1)

21287

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

StemlineTherapeutics, Inc.

UNKNOWN

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT05716009 - Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML | Biotech Hunter | Biotech Hunter