NCT05662904View on ClinicalTrials.gov

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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 31, 2028

Primary Completion Date

January 31, 2029

Study Completion Date

January 31, 2030

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.

Trial Locations (2)

69120

University Hospital Heidelberg, Internal Medicine V, Heidelberg

01307

University Hospital Dresden, Department of Medicine I, Dresden

All Listed Sponsors
collaborator

University Hospital Heidelberg

OTHER

collaborator

University Hospital Dresden

OTHER

lead

German Cancer Research Center

OTHER