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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide
Institut Paoli Calmettes
Marseille, France
RECRUITINGCentre hospitalier universitaire de Nantes
Nantes, France
RECRUITINGHôpital Saint-Louis
Paris, France
RECRUITINGOccurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.
To evaluate the safety of SMART101.
Time frame: 14 days post SMART101 infusion
CD4+ T cell count.
to evaluate the efficacy of the study drug
Time frame: 100 days post-HSCT
Occurrence of adverse events (AEs)
Time frame: 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
Time frame: up to 12 months post-HSCT
Cumulative incidence of infections
Time frame: Day 100, and Months 6 and 12 post-HSCT
Non-relapse mortality (NRM)
Time frame: Day 100, and Months 6, 12 and 24 post-HSCT
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CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Toulouse, France
RECRUITING