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SMART101 for Hematological Malignancies After T Cell Depleted Allo-HSCT

This study is testing a treatment called SMART101 (Human T Lymphoid Progenitor or HTLP) for people with blood cancers (hematological malignancies) who have had a special type of stem cell transplant (T cell depleted allogeneic hematopoietic stem cell transplantation or allo-HSCT). The goal is to see if SMART101 is safe and helps the immune system recover faster after the transplant. Researchers will give you an injection of SMART101 a few days after your transplant. They will be looking at how many people get a serious side effect called GvHD (graft-versus-host disease), any other side effects from SMART101, and how your immune cells (CD4+ T cells) recover. This study is for both adults and children, including those with certain types of acute leukemia.

Study design
This is an interventional study planning to enroll 36 participants. The phase is not specified, and the current status is unclear.
What's involved
You would receive an injection of T cell progenitors between 4 and 10 days after your stem cell transplant. The study will monitor your health for at least 100 days after the transplant.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 100 days post-HSCT, indicating a follow-up period of at least 100 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04959903

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

Recruiting
PHASE1All AgesInterventionalTreatment
Smart Immune SAS
~36 participants
Updated 2023-03-06 on ClinicalTrials.gov
What's tested:Allogeneic T cell progenitors, cultured ex-vivo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative incidence of grade III-IV GvHD
Measured over 100 days post-HSCT
+2 more outcomes measured

Conditions

Hematological Malignancies

Explore related trials

Acute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Frédéric LEHMANN, MD
[email protected]
+32 (0) 492 46 23 55
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

What this trial measures

  • Cumulative incidence of grade III-IV GvHD100 days post-HSCT

    to evaluate the safety profile of the study drug

  • Occurrence of adverse events related to SMART101100 days post-HSCT

    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

  • CD4+ T cell count100 days post-HSCT

    to evaluate the efficacy of the study drug