RecruitingPhase 1Phase 2NCT05768035

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

Sponsor

Smart Immune SAS

Enrollment

40 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Hematological Malignancies

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria3

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.