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

Hematological Malignancies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768035
• Other study ID #: SI101-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

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