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Tests treatment safety and results for Hematological Malignancies
Official title Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT
ClinicalTrials.gov ID: NCT04959903
What this study is testing
What is Allogeneic T cell progenitors, cultured ex-vivo?
Allogeneic T cell progenitors, cultured ex-vivo is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hematological malignancies.
Also referred to as SMART101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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
You likely can't join 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
- Treatment with another cellular therapy within one month before inclusion
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.