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The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT | Experimental | Segment 1: 3 dose-level SMART101 cells/infusion
Segment 2: 2 cohorts of patients will be included in the study based on the type of conditioning regimen:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic T cell progenitors, cultured ex-vivo | Biological | Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101. | To evaluate the safety of SMART101. | 14 days post SMART101 infusion |
| CD4+ T cell count. | to evaluate the efficacy of the study drug | 100 days post-HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) | up to 24 months post-HSCT | |
| T cell immune reconstitution | Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Month 24 post-HSCT | |
| Disease-free Survival | Month 24 post-HSCT |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric LEHMANN, MD | Contact | +32 (0) 492 46 23 55 | frederic.lehmann@smart-immune.com | |
| Aurélie BAUQUET, PhD | Contact | aurelie.bauquet@smart-immune.com |
| Name | Affiliation | Role |
|---|---|---|
| Fabio CICERI, MD, Pr. | I.R.C.C.S. Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Recruiting | Marseille | 13009 | France |
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Phase I/II, open-label, dose-escalation, single arm, multicenter study.
This study will comprise two segments:
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|
| up to 12 months post-HSCT |
| Cumulative incidence of infections | Day 100, and Months 6 and 12 post-HSCT |
| Non-relapse mortality (NRM) | Day 100, and Months 6, 12 and 24 post-HSCT |
| Centre hospitalier universitaire de Nantes | Recruiting | Nantes | 44093 | France |
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| Hôpital Saint-Louis | Recruiting | Paris | 75010 | France |
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| CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole | Recruiting | Toulouse | 31059 | France |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D052517 | Multiple Sulfatase Deficiency Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D052516 | Sulfatidosis |
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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