RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-03-31

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04959903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Patient eligible for a T-depleted allogeneic HSCT 3. Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation 4. Karnofsky index ≥ 70% prior to conditioning regimen 5. Patients with normal organ function prior to conditioning regimen 1. 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) 2. Patient eligible for a T-depleted allogeneic HSCT 3. Age \< 18y at the time of inclusion 4. Absence of a matched sibling donor (MSD) 5. Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen 6. Patients with normal organ function prior to conditioning regimen	1. Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor 2. Prior therapy with allogeneic stem cell transplantation 3. Treatment with another cellular therapy within one month before inclusion

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Patient eligible for a T-depleted allogeneic HSCT
3. Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
4. Karnofsky index ≥ 70% prior to conditioning regimen
5. Patients with normal organ function prior to conditioning regimen
1. 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)
2. Patient eligible for a T-depleted allogeneic HSCT
3. Age \< 18y at the time of inclusion
4. Absence of a matched sibling donor (MSD)
5. Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen
6. Patients with normal organ function prior to conditioning regimen

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

Contacts and Locations

Study Contact

Frédéric LEHMANN, MD

CONTACT

+32 (0) 492 46 23 55

frederic.lehmann@smart-immune.com

Laura SIMONS, MD, PhD

CONTACT

laura.simons@smart-immune.com

Principal Investigator

Jaap-Jan BOELENS, MD, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center (MSKCC)

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Smart Immune SAS

Jaap-Jan BOELENS, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center (MSKCC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-31

Study Completion Date2027-05

Study Record Updates

Study Start Date2022-03-31

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Hematological Malignancies