Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

Part of paid clinical trials in New York, New York.

Sponsor
Smart Immune SAS
Study ID
NCT04959903
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic T cell progenitors, cultured ex-vivo — BIOLOGICAL
    Injection of T cell progenitors at \[Day 4-Day 10\] after T cell depleted allogeneic HSCT

Study Details

The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.

Key Dates

Start date
Mar 31, 2022
Status verified
Mar 2023
Primary completion
Aug 31, 2025
Completion
May 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adult patients affected by hematological malignancies
    Adult patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) or myelodysplastic syndrome eligible for a T depleted allogeneic HSCT
  • Experimental: Pediatric patients affected by hematological malignancies
    Pediatric patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) eligible for a T depleted allogeneic HSCT

Primary Outcome Measure

Cumulative incidence of grade III-IV GvHD [ Time Frame: 100 days post-HSCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (MSKCC)New YorkNew York10065
Jaap-Jan BOELENS, MD, PhD (PRINCIPAL_INVESTIGATOR)
Miguel-Angel PERALES, MD (SUB_INVESTIGATOR)

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By research site
Memorial Sloan Kettering Cancer Center (MSKCC)· New York, NY

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