NCT05662904

Genetic Ablation of CD33 in Hematopoietic Stem Cells to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with Acute Myeloid Leukemia (AML)

Study Summary

The study "GALAXY33" is an open-label, prospective, nonrandomized, one arm phase I clinical trial in which patients with relapsed AML after allogeneic hematopoietic stem cell transplantation will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor.

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Interventions

Donor-derived CD34+ HSC with CRISPR/Cas9-mediated CD33 deletionBIOLOGICAL
CD33-deleted CD34+ hematopoietic stem cells derived from the initially matched family donor
Gemtuzumab OzogamicinDRUG
Intrapatient intra-individual dose escalation Level 0: GO day 1 Level 1: GO day 1, day 4 Level 2: GO day 1, day 4, day 7 with repetition after 21 to 28 days up to 84 days.

Study Locations

FacilityCityStateCountry
University Hospital Dresden, Department of Medicine IDresdenGermany
University Hospital Heidelberg, Internal Medicine VHeidelbergGermany

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026