Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

Eligibility Criteria

• 1. Adult patients affected by:
• * Acute leukemia (AML, ALL) defined as:
• * Acute Myeloid Leukemia (AML):
• * High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities
• * Chemo-refractory relapse (MRD+)
• * ≥ CR2
• * Acute Lymphoblastic Leukemia (ALL):
• * Chemo-refractory relapse (MRD+)
• * High risk ALL in CR1; Philadelphia (like) or any poor risk feature
• * ≥ CR2
• * Acute leukemia of ambiguous lineage:
• * ≥ CR1 with a minimal residual disease (MRD) \<5% (flow cytometry, molecular and/or cytogenetics accepted)
• * Myelodysplastic Syndrome (MDS) with least one of the following:
• * Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
• * Life-threatening cytopenia.
• * Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
• * Therapy related disease or disease evolving from other malignant processes.
• 2. Patient eligible for a T-depleted allogeneic HSCT
• 3. Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
• 4. Karnofsky index ≥ 70% prior to conditioning regimen
• 5. Patients with normal organ function prior to conditioning regimen
• 1. Pediatric patients affected by acute leukemia defined as:
• * Acute Myeloid Leukemia (AML):
• * High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities,
• * Chemo-refractory relapse (MRD+)
• * ≥ CR2
• * Acute Lymphoblastic Leukemia (ALL):
• * Chemo-refractory relapse (MRD+)
• * High risk ALL in CR1; Philadelphia (like) or any poor risk feature
• * ≥ CR2
• * Acute leukemia of ambiguous lineage:
• * ≥ CR1 with a minimal residual disease (MRD) \<5% (flow cytometry, molecular and/or cytogenetics accepted)
• 2. Patient eligible for a T-depleted allogeneic HSCT
• 3. Age \< 18y at the time of inclusion
• 4. Absence of a matched sibling donor (MSD)
• 5. Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen
• 6. Patients with normal organ function prior to conditioning regimen
• 1. Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor
• 2. Prior therapy with allogeneic stem cell transplantation
• 3. Treatment with another cellular therapy within one month before inclusion