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

Recruiting now · Phase 1/Phase 2

Conditions studied: Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT04959903

Run by

Smart Immune SAS

People needed

36

Starts

2022-03-31

Expected to finish

2027-05-01

Last updated by the study team

2023-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Group A (adults):
• 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.
• Patient eligible for a T-depleted allogeneic HSCT
• Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
• Karnofsky index ≥ 70% prior to conditioning regimen
• Patients with normal organ function prior to conditioning regimen
• Group B (pediatrics):
• Pediatric patients affected by acute leukemia defined as:
• Acute Myeloid Leukemia (AML):

You may not qualify if…

• Groups A and B:
• Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor
• Prior therapy with allogeneic stem cell transplantation
• Treatment with another cellular therapy within one month before inclusion

Where it is running

• Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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