Actively Recruiting

Phase 1
Phase 2
All Genders
NCT04959903

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

Led by Smart Immune SAS · Updated on 2023-03-06

36

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with high-risk acute leukemia or myelodysplastic syndrome eligible for T cell depleted allogeneic HSCT
  • Age 18 years or older with clinical condition suitable for allogeneic stem cell transplant
  • Karnofsky performance status 70% or higher before conditioning
  • Normal organ function prior to conditioning
  • Pediatric patients with high-risk acute leukemia eligible for T cell depleted allogeneic HSCT
  • Age under 18 years at inclusion
  • No matched sibling donor available
  • Lansky or Karnofsky performance status 70% or higher before conditioning
  • Normal organ function prior to conditioning
Not Eligible

You will not qualify if you...

  • Use of an HLA matched cord blood or haploidentical donor
  • Previous allogeneic stem cell transplant
  • Treatment with another cellular therapy within one month before inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, United States, 10065

Actively Recruiting

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Research Team

F

Frédéric LEHMANN, MD

CONTACT

L

Laura SIMONS, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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