RecruitingPhase 1Phase 2NCT05768035

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

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


Sponsor

Smart Immune SAS

Enrollment

40 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SMART101, a specialized immune cell therapy, in patients with blood cancers (leukemia or pre-leukemia) who are receiving a bone marrow transplant from a half-matched family donor. The goal is to reduce the risk of relapse and improve immune recovery after transplant. **You may be eligible if...** - You are 18 or older - You have AML (acute myeloid leukemia), ALL (acute lymphoblastic leukemia), or MDS (myelodysplastic syndrome) - You are eligible for a bone marrow transplant from a half-matched (haploidentical) family donor - You have adequate heart, lung, liver, and kidney function - Your Karnofsky performance score is 70 or higher (able to carry out normal activity with some effort) **You may NOT be eligible if...** - You have other serious medical conditions that would prevent transplant - You do not have a suitable haploidentical donor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAllogeneic 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(4)

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, France

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NCT05768035


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