NCT05662904Not yet recruitingPhase 1
Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML
Genetic Ablation of CD33 in Hematopoietic Stem Cells to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 6 Dec 2022
- Start date
- Jan 2028
- Primary completion date
- Jan 2029
- Lead sponsor
- German Cancer Research Center
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05662904
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From Jan 2028 to the primary completion date, Jan 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with GO
- Prior hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
- Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)
- Unstable angina and/or myocardial infarction within 3 months prior to screening
Other illness
- Acute or chronic Graft versus Host disease (GvHD)
- Uncontrolled active hepatitis B or C
- HIV-positivity
- Uncontrolled bacterial, viral or fungal infection
- Organ dysfunction (liver, kidney, lung, heart) that is a contraindication for conditioning therapy
Other
- ECOG performance status \>2
- Confirmed CNS involvement
- Availability of other curative standard treatment options
- Participation in another clinical trial at the time of screening
- Pregnant or nursing (lactating) women
Who the study is looking for
- 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
- confirmed CD33 expression on leukemic blasts at current relapse (as detected by flow cytometry)
- adequate organ function:
- Renal function defined as: serum creatinine of ≤ 2x ULN or eGFR ≥ 30 mL/min/1.73 m2
- Liver function defined as:
- ALT ≤ 3 times the ULN for the respective age
- Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)
- Minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \> 90% on room air
- Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram
- Absolute lymphocyte count (ALC) ≥ 100/mm3
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Dresden, Department of Medicine I Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University Hospital Heidelberg, Internal Medicine V Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.