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

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.

Trial Details

NCT ID
NCT05768035
Phase
PHASE1 / PHASE2
Sponsor
Smart Immune SAS
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Allogeneic T cell progenitors, cultured ex-vivo
Locations (sample)
  • Marseille, France|43.29695,5.38107
  • Nantes, France|47.21725,-1.55336
  • Paris, France|48.85341,2.3488
  • Toulouse, France|43.60426,1.44367

Key Eligibility 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%.

For full eligibility, visit ClinicalTrials.gov.

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