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

ConditionRelapsed/Refractory Acute Myeloid Leukemia (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

Locations

University Hospital Dresden, Department of Medicine I01307, Dresden Germany

University Hospital Heidelberg, Internal Medicine V69120, Heidelberg Germany

Sponsors and collaborators

German Cancer Research Center

Lead sponsor

University Hospital Heidelberg

Collaborator

University Hospital Dresden

Collaborator

Source ClinicalTrials.gov