MedTrace Logo

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

NCT05662904 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-14

No results posted yet for this 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.

Conditions

  • Relapsed/Refractory Acute Myeloid Leukemia (AML)

Interventions

BIOLOGICAL

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

CD33-deleted CD34+ hematopoietic stem cells derived from the initially matched family donor

DRUG

Gemtuzumab Ozogamicin

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.

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • University Hospital Dresden

    collaborator OTHER

  • German Cancer Research Center

    lead OTHER

Principal Investigators

  • Tim Sauer, Dr. med. · University Hospital Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-31
Primary Completion
2029-01-31
Completion
2030-01-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05662904 on ClinicalTrials.gov