Evaluating SMART101 for immune recovery in patients with blood cancers after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of SMART101, a human T lymphoid progenitor injection, to enhance immune recovery in both pediatric and adult patients who have undergone T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) due to hematological malignancies. The trial will involve administering cultured ex-vivo T cell progenitors to participants and monitoring their immune response and overall health outcomes. It is designed to provide insights into how this innovative treatment can improve recovery times and reduce complications associated with HSCT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Group A (adults):

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

Group B (pediatrics):

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

Exclusion Criteria:

Groups A and B:

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

Where it's running

• Memorial Sloan Kettering Cancer Center (MSKCC)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jaap-Jan BOELENS, MD, PhD — Memorial Sloan Kettering Cancer Center (MSKCC)
• Study coordinator: Frédéric LEHMANN, MD
• Email: frederic.lehmann@smart-immune.com
• Phone: +32 (0) 492 46 23 55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.