Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGerman Cancer Research Center

About this trial

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.

Eligibility criteria

Qualifiers

confirmed AML according to the WHO classification

relapsed disease after allo-SCT from an HLA-identical family donor (≥ 2 months after allo-SCT at time of inclusion)

≤ 29% of bone marrow blasts as detected by cytomorphology or immunohistochemistry

age ≥ 18 years

Disqualifiers

ECOG performance status >2

Confirmed CNS involvement

Acute or chronic Graft versus Host disease (GvHD)

Availability of other curative standard treatment options

Trial design

Treatments tested in this trial

  • Donor-derived CD34+ HSC with CRISPR/Cas9-mediated CD33 deletion
  • Gemtuzumab Ozogamicin

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

German Cancer Research Center

Lead sponsor

University Hospital Heidelberg

Collaborator

University Hospital Dresden

Collaborator