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Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT05768035
Recruitment Status : Recruiting
First Posted : March 14, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Smart Immune SAS

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Biological: Allogeneic T cell progenitors, cultured ex-vivo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
  • Phase I/II, open-label, dose-escalation, single arm, multicenter study.

  • This study will comprise two segments:

    • A phase I dose-escalation segment: Three (3) prespecified dose-levels of SMART101 will be evaluated in three consecutive cohorts of patients whatever the type of conditioning regimen the patients will receive before the HSCT to define the SMART101 recommended dose (RecD).
    • A phase II segment: once all patients from the dose-escalation segment have completed their "treatment period " and the SMART101 RecD has been defined, a total number of 34 patients will be enrolled at the RecD in the phase II segment of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies
Actual Study Start Date : June 6, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT

Segment 1: 3 dose-level SMART101 cells/infusion

  1. 1.5 x 106 CD7+ cells per kg of body weight
  2. 4.5 x 106 CD7+ cells per kg of body weight
  3. 9.0 x 106 CD7+ cells per kg of body weight

Segment 2:

2 cohorts of patients will be included in the study based on the type of conditioning regimen:

  • The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC).
  • The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC).
  • Enrollment of patients in each cohort will be done in parallel.
 Biological: Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide
Other Name: SMART101


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101. [ Time Frame: 14 days post SMART101 infusion ]
    To evaluate the safety of SMART101.

  2. CD4+ T cell count. [ Time Frame: 100 days post-HSCT ]
    to evaluate the efficacy of the study drug


Secondary Outcome Measures :
  1. Occurrence of adverse events (AEs) [ Time Frame: up to 24 months post-HSCT ]
  2. T cell immune reconstitution [ Time Frame: up to 12 months post-HSCT ]
    Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells

  3. Cumulative incidence of infections [ Time Frame: Day 100, and Months 6 and 12 post-HSCT ]
  4. Non-relapse mortality (NRM) [ Time Frame: Day 100, and Months 6, 12 and 24 post-HSCT ]

Other Outcome Measures:
  1. Overall Survival (OS) [ Time Frame: Month 24 post-HSCT ]
  2. Disease-free Survival [ Time Frame: Month 24 post-HSCT ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.
  • Patients must be ≥ 18 years of age at the time of signing the ICF.
  • Patients must have a Karnofsky index ≥ 70%.
  • Patients must have a left ventricular ejection fraction of ≥40%.
  • Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.
  • Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.

Main Exclusion Criteria:

  • Patients who have received prior allogeneic stem cell transplantation.
  • Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.
  • Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05768035


Contacts
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Contact: Frédéric LEHMANN, MD +32 (0) 492 46 23 55 frederic.lehmann@smart-immune.com
Contact: Aurélie BAUQUET, PhD aurelie.bauquet@smart-immune.com

Locations
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France
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Principal Investigator: Raynier Devillier, Pr         
Centre hospitalier universitaire de Nantes Recruiting
Nantes, France, 44093
Principal Investigator: Patrice Chevallier, MD, PhD         
Hôpital Saint-Louis Recruiting
Paris, France, 75010
Principal Investigator: Régis Peffault de Latour, Pr         
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole Recruiting
Toulouse, France, 31059
Principal Investigator: Anne Huynh, MD         
Sponsors and Collaborators
Smart Immune SAS
Investigators
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Principal Investigator: Fabio CICERI, MD, Pr. I.R.C.C.S. Ospedale San Raffaele
More Information
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Responsible Party: Smart Immune SAS
ClinicalTrials.gov Identifier: NCT05768035    
Other Study ID Numbers: SI101-02
First Posted: March 14, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Smart Immune SAS:
AML, ALL, MSD
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases