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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide

An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Main Who May Qualify: - Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide. - Patients must be ≥ 18 years of age at the time of signing the ICF. - Patients must have a Karnofsky index ≥ 70%. - Patients must have a left ventricular ejection fraction of ≥40%. - Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted. - Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria. Main Who Should NOT Join This Trial: - Patients who have received prior allogeneic stem cell transplantation. - Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion. - Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Main Inclusion Criteria: * Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide. * Patients must be ≥ 18 years of age at the time of signing the ICF. * Patients must have a Karnofsky index ≥ 70%. * Patients must have a left ventricular ejection fraction of ≥40%. * Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted. * Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria. Main Exclusion Criteria: * Patients who have received prior allogeneic stem cell transplantation. * Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion. * Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.

Treatments Being Tested

BIOLOGICAL

Allogeneic T cell progenitors, cultured ex-vivo

Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide

Locations (4)

Institut Paoli Calmettes
Marseille, France
Centre hospitalier universitaire de Nantes
Nantes, France
Hôpital Saint-Louis
Paris, France
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Toulouse, France