Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

CRISPR/Cas9-mediated inactivation of CD33 in hematopoietic stem cells (HSC) may broaden the therapeutic index of CD33-directed immunotherapy for patients with AML by rendering healthy hematopoietic stem and progenitor cells (HSPC) resistant to escalating doses and/or shorter dosing intervals of the CD33-specific antibody-drug conjugate (ADC) Gemtuzumab-ozogamicin (GO). In this proof of concept trial, we will develop a platform for genome editing of CD34+ HSC and demonstrate the feasibility, safety and efficacy of this approach for targeted therapy of AML. Upon implementation, the platform shall be used for innovative clinical trials in diverse types of cancer. Outside of leukemias, autologous HSC could be used to ease the procedure. 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. Upon HSC engraftment, patients will be treated with escalating doses of the anti-CD33 antibodydrug conjugate Gemtuzumab-Ozogamicin (GO). A conditioning regimen containing GO (d-14, d-11, d-8),Fludarabine 30 mg/m2 (d-6 to d-3) and Melphalan 140mg/m2 (d-2) is used prior to transplantation. The clinical trial will be conducted at two trial sites in the University Hospitals in Heidelberg and Dresden. 25 patients will be assessed for eligibility and 12 patients will be allocated into the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05662904
Study type Interventional
Source German Cancer Research Center
Contact Tim Sauer, Dr. med.
Phone +49 6221 56 38010
Email tim.sauer@med.uni-heidelberg.de
Status Not yet recruiting
Phase Phase 1
Start date December 2023
Completion date February 2025

See also
  Status Clinical Trial Phase
Terminated NCT03541369 - Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT05143996 - CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Phase 1
Completed NCT02626338 - Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML Phase 1/Phase 2
Recruiting NCT06049667 - A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies Phase 1