A Phase I/II Study Evaluating 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 in Pediatric and Adult Patients with Acute Leukemia
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What's the purpose of this trial?

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 relapsed/refractory acute leukemia.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Group A (adults):
    • Adult patients affected by acute leukemia (AML, ALL) defined as:
      • Acute Myeloid Leukemia (AML):
      • High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities
      • Chemo-refractory relapse (MRD+)
      • ≥ CR2
    • Acute Lymphoblastic Leukemia (ALL):
      • Chemo-refractory relapse (MRD+)
      • High risk in CR1; Philadelphia (like) or any poor risk feature
      • ≥ CR2
    • Patient eligible for an allogeneic HSCT
    • Age ≥ 21y and clinical condition compatible with allogeneic bone marrow transplantation
    • Karnofsky index ≥ 70%
    • Patients with normal organ function
  • Group B (pediatrics):
    • Pediatric patients affected by acute leukemia (AML, ALL) defined as:
      • Acute Myeloid Leukemia (AML):
      • High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities,
      • Chemo-refractory relapse (MRD+)
      • ≥ CR2
    • Acute Lymphoblastic Leukemia (ALL):
      • Chemo-refractory relapse (MRD+)
      • High risk in CR1; Philadelphia (like) or any poor risk feature
      • ≥ CR2
  • Patient eligible for an allogeneic HSCT
  • Age < 21y at the time of inclusion
  • Absence of a matched sibling donor (MSD)
  • Lansky ≥ 70% / Karnofsky ≥ 70%
  • Patients with normal organ function

Exclusion Criteria:

  • Groups A and B:
    • Planned use of an HLA matched CB (8/8 allele matched).
    • Prior therapy with allogeneic stem cell transplantation
    • Treatment with another cellular therapy within one month before inclusion

Additional Trial Information

Phase 1/2

Enrollment: 36 patients (estimated)

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Trial Locations

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New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting
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