NCT04959903

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
12mo left

Started Mar 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2022May 2027

First Submitted

Initial submission to the registry

July 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

3.3 years

First QC Date

July 1, 2021

Last Update Submit

March 2, 2023

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (3)

  • Cumulative incidence of grade III-IV GvHD

    to evaluate the safety profile of the study drug

    100 days post-HSCT

  • Occurrence of adverse events related to SMART101

    Number of adverse events and serious adverse events related to SMART101 tabulated for each dose and by age group to evaluate the safety profile of the study drug

    100 days post-HSCT

  • CD4+ T cell count

    to evaluate the efficacy of the study drug

    100 days post-HSCT

Secondary Outcomes (3)

  • T cell immune reconstitution

    up to Month 12 post-HSCT

  • Cumulative incidence of infections

    Day 90, and Months 6, 12 and 24 post-HSCT

  • Non-relapse mortality (NRM)

    Day 90, and Months 6, 12 and 24 post-HSCT

Other Outcomes (2)

  • Overall Survival (OS)

    Month 24 post-HSCT

  • Disease-free Survival

    Month 24 post-HSCT

Study Arms (2)

Adult patients affected by hematological malignancies

EXPERIMENTAL

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

Biological: Allogeneic T cell progenitors, cultured ex-vivo

Pediatric patients affected by hematological malignancies

EXPERIMENTAL

Pediatric patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) eligible for a T depleted allogeneic HSCT

Biological: Allogeneic T cell progenitors, cultured ex-vivo

Interventions

Allogeneic T cell progenitors, cultured ex-vivoBIOLOGICAL

Injection of T cell progenitors at \[Day 4-Day 10\] after T cell depleted allogeneic HSCT

Also known as: SMART101
Adult patients affected by hematological malignanciesPediatric patients affected by hematological malignancies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +23 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jaap-Jan BOELENS, MD, PhD

    Memorial Sloan Kettering Cancer Center (MSKCC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric LEHMANN, MD

CONTACT

+32 (0) 492 46 23 55frederic.lehmann@smart-immune.com

Laura SIMONS, MD, PhD

CONTACT

laura.simons@smart-immune.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 13, 2021

Study Start

March 31, 2022

Primary Completion

August 1, 2025

Study Completion (Estimated)

May 1, 2027

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)