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    DRUG:

    SMART 101

    i
    Other names: SMART 101, SMART101
    Associations

    News

    Trials
    Company:
    Smart Immune
    Drug class:
    Cell therapy
    Related drugs:
    Associations

    News

    Trials
    1year
    SMART101 Donor T-Lymphoid Progenitors to Accelerate Immune Reconstitution Post-Haploidentical Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide: SI101-02 First-in-Human Phase I/II (ASH 2023)
    Conclusion SMART101 is the first-generation of allogeneic TLP cell therapy obtained from Smart Immune's proprietary GMP manufacturing platform. The duration and the depth of T cell immunodeficiency post haplo PTCy HSCT is expected to be significantly reduced by the infusion of SMART101 thereby decreasing the non-relapse mortality and morbidity rates and thus improving the overall clinical outcome of this therapy.
    P1/2 data • Post-transplantation
    |
    CD34 (CD34 molecule) • CD7 (CD7 Molecule)
    |
    cyclophosphamide • SIRPant-M (SI-101) • SMART 101
    1year
    Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Smart Immune SAS | Trial completion date: Oct 2026 --> Jul 2026 | Trial primary completion date: Jan 2025 --> Jul 2025
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    CD4 (CD4 Molecule)
    |
    cyclophosphamide • SMART 101
    over1year
    Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide (clinicaltrials.gov)
    P1/2, N=34, Recruiting, Smart Immune SAS | Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023
    Enrollment open • Trial initiation date
    |
    CD4 (CD4 Molecule)
    |
    cyclophosphamide • SMART 101
    over1year
    SI101-01 PHASE I/II STUDY EVALUATING SAFETY AND EFFICACY OF ALLOGENEIC SMART101 T-LYMPHOID PROGENITOR INJECTION TO ACCELERATE IMMUNE RECONSTITUTION AFTER T-CELL DEPLETED ALLOGENEIC HSCT (EHA 2023)
    SMART101 is the first-generation of allogeneic T lymphoid progenitor cells obtained through Smart Immune's ProTcell platform, the first scalable progenitor T-cell manufacturing system in clinics. The early data indicate that SMART101 is well tolerated with a good safety profile. Thymic function, Post-transplant, CD4+ T cells, Allogeneic hematopoietic stem cell transplant
    Clinical • P1/2 data
    |
    CXCR4 (Chemokine (C-X-C motif) receptor 4) • CD34 (CD34 molecule) • CD7 (CD7 Molecule) • MLANA (Melan-A) • KLRB1 (Killer Cell Lectin Like Receptor B1)
    |
    SIRPant-M (SI-101) • SMART 101
    over1year
    SMART101 DONOR T-LYMPHOID PROGENITORS TO ACCELERATE IMMUNE RECONSTITUTION POST-HAPLOIDENTICAL PERIPHERAL BLOOD STEM CELL TRANSPLANTATION WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE: SI101-02 PHASE I/II (EHA 2023)
    SMART101 is the first-generation of allogeneic T lymphoid progenitor cell therapy obtained from Smart Immune's proprietary ProTcell platform, the first scalable progenitor T-cell manufacturing system in clinics. Notch, Thymus, Post-transplant, Allogeneic hematopoietic stem cell transplant
    P1/2 data • Post-transplantation
    |
    CXCR4 (Chemokine (C-X-C motif) receptor 4) • CD34 (CD34 molecule) • CD7 (CD7 Molecule) • MLANA (Melan-A) • KLRB1 (Killer Cell Lectin Like Receptor B1) • SELP (Selectin P)
    |
    cyclophosphamide • SIRPant-M (SI-101) • SMART 101
    over1year
    Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide (clinicaltrials.gov)
    P1/2, N=34, Not yet recruiting, Smart Immune SAS
    New P1/2 trial • Post-transplantation
    |
    CD4 (CD4 Molecule)
    |
    cyclophosphamide • SMART 101
    over1year
    Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT (clinicaltrials.gov)
    P1/2, N=36, Recruiting, Smart Immune SAS | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Mar 2025 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • CD4 (CD4 Molecule)
    |
    TP53 mutation
    |
    SMART 101
    almost3years
    Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Acute Leukemia After T Cell Depleted Allo-HSCT (clinicaltrials.gov)
    P1/2, N=36, Recruiting, Smart Immune SAS | Not yet recruiting --> Recruiting | Trial completion date: Sep 2026 --> Dec 2026 | Initiation date: Sep 2021 --> Dec 2021 | Trial primary completion date: Dec 2024 --> Mar 2025
    Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    SMART 101
    over3years
    Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Acute Leukemia After T Cell Depleted Allo-HSCT (clinicaltrials.gov)
    P1/2, N=36, Not yet recruiting, Smart Immune SAS
    Clinical • New P1/2 trial
    |
    CD4 (CD4 Molecule)
    |
    SMART 101