NCT04959903 Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 36 participants in total. It began in 2022-03-31 with a primary completion date of 2025-08.

Brief Summary

The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.

Eligibility Criteria

Inclusion Criteria: Group A (adults): 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 Group B (pediatrics): 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 Exclusion Criteria: Groups A and B: 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

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