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Recruiting NCT04959903

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

Phase I / Phase II Interventional Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allogeneic T cell progenitors, cultured ex-vivo.
Who it may be relevant to
Registry conditions: Hematological Malignancies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II Study Evaluating the Safety and the Efficacy of SMART101 Injection to Accelerate Immune Reconstitution After T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric and Adult Patients With Hematological Malignancies

Overview

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.

Interventions

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

Primary outcome measures

  • Cumulative incidence of grade III-IV GvHD [Time frame: 100 days post-HSCT]
  • Occurrence of adverse events related to SMART101 [Time frame: 100 days post-HSCT]
  • CD4+ T cell count [Time frame: 100 days post-HSCT]
Secondary outcome measures (3)
  • T cell immune reconstitution [Time frame: up to Month 12 post-HSCT]
  • Cumulative incidence of infections [Time frame: Day 90, and Months 6, 12 and 24 post-HSCT]
  • Non-relapse mortality (NRM) [Time frame: Day 90, and Months 6, 12 and 24 post-HSCT]

Eligibility criteria

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 ALL in CR1; Philadelphia (like) or any poor risk feature
  • ≥ CR2
  • Acute leukemia of ambiguous lineage:
  • ≥ CR1 with a minimal residual disease (MRD) <5% (flow cytometry, molecular and/or cytogenetics accepted)
  • Myelodysplastic Syndrome (MDS) with least one of the following:
  • Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
  • Life-threatening cytopenia.
  • Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
  • Therapy related disease or disease evolving from other malignant processes.
  • Patient eligible for a T-depleted allogeneic HSCT
  • Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
  • Karnofsky index ≥ 70% prior to conditioning regimen
  • Patients with normal organ function prior to conditioning regimen

Group B (pediatrics):

  • Pediatric patients affected by acute leukemia 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 ALL in CR1; Philadelphia (like) or any poor risk feature
  • ≥ CR2
  • Acute leukemia of ambiguous lineage:
  • ≥ CR1 with a minimal residual disease (MRD) <5% (flow cytometry, molecular and/or cytogenetics accepted)
  • Patient eligible for a T-depleted allogeneic HSCT
  • Age < 18y at the time of inclusion
  • Absence of a matched sibling donor (MSD)
  • Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen
  • Patients with normal organ function prior to conditioning regimen

Exclusion criteria

Groups A and B:

  • Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor
  • Prior therapy with allogeneic stem cell transplantation
  • Treatment with another cellular therapy within one month before inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Memorial Sloan Kettering Cancer Center (MSKCC) — New York

Identifiers

NCT: NCT04959903 · SI101-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗