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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768035
Other study ID # SI101-02
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 6, 2023
Est. completion date July 2026

Study information

Verified date September 2023
Source Smart Immune SAS
Contact Frédéric LEHMANN, MD
Phone +32 (0) 492 46 23 55
Email frederic.lehmann@smart-immune.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
France Institut Paoli Calmettes Marseille
France Centre hospitalier universitaire de Nantes Nantes
France Hôpital Saint-Louis Paris
France CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Smart Immune SAS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall Survival (OS) Month 24 post-HSCT
Other Disease-free Survival Month 24 post-HSCT
Primary Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101. To evaluate the safety of SMART101. 14 days post SMART101 infusion
Primary CD4+ T cell count. to evaluate the efficacy of the study drug 100 days post-HSCT
Secondary Occurrence of adverse events (AEs) up to 24 months post-HSCT
Secondary T cell immune reconstitution Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells up to 12 months post-HSCT
Secondary Cumulative incidence of infections Day 100, and Months 6 and 12 post-HSCT
Secondary Non-relapse mortality (NRM) Day 100, and Months 6, 12 and 24 post-HSCT
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