Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for adults with Acute Myeloid Leukemia (AML) who have achieved a state of remission but still have some cancer cells present, known as minimal residual disease (MRD). The researchers want to see if infusing special immune cells called alloreactive natural killer (NK) cells, which come from a closely matched donor, can help these patients. To participate, patients must be at least 18 years old, have a specific type of AML, and have a compatible donor available. They also need to be well enough to undergo the treatment and meet certain health criteria.

Participants in this trial can expect to receive a combination of chemotherapy to prepare their bodies for the NK cell infusion. After the infusion, they will receive additional treatment to help the NK cells work effectively. Throughout the trial, patients will have regular check-ups and tests to monitor their health and to study how well the NK cells are performing. The entire process is designed to last at least 12 months, during which researchers will gather important information to better understand the effectiveness of this treatment for AML patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of de novo or secondary AML
• • Age ≥ 18 years
• • Morphologic CR
• • Eligibility for ASCT
• • MRD-positivity after induction chemotherapy
• • Availability of a KIR-L incompatible haploidentical donor
• • Performance Status ≥ 70% (Karnofsky score) or ≤ 2 (WHO).
• • Adequate renal (serum creatinine \< 2 mg/dl), pulmonary (Sat O2 ≥ 96%) and hepatic (ALT/AST \< 2.5 x N) function.
• • Left Ventricular Ejection Fraction (LVEF) of \>50% as determined by Echocardiogram (ECHO).
• • Signed informed consent.
• Exclusion Criteria:
• • Diagnosis of AML FAB M3
• • HIV positivity.
• • HCV positivity with high viral load.
• • Pregnant or nursing females.
• • Current uncontrolled infection.
• • Signs or symptoms of fluid retention (e.g. pleural effusion).

Trial Officials