Actively Recruiting
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
Led by Smart Immune SAS · Updated on 2023-09-25
40
Participants Needed
4
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with AML, ALL, or MDS eligible for allogeneic HSCT with a haploidentical donor and post-transplant cyclophosphamide
- 18 years of age or older at the time of signing informed consent
- Karnofsky performance status of 70% or higher
- Left ventricular ejection fraction of 40% or higher
- Intact pulmonary function or DLCO of 45% or higher of predicted
- Adequate liver and kidney function based on standard laboratory tests
You will not qualify if you...
- Prior allogeneic stem cell transplantation
- Treatment with another cellular therapy within 4 weeks before planned SMART101 infusion
- Receipt of investigational agents within 4 weeks before planned SMART101 infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
2
Centre hospitalier universitaire de Nantes
Nantes, France, 44093
Actively Recruiting
3
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
4
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Toulouse, France, 31059
Actively Recruiting
Research Team
F
Frédéric LEHMANN, MD
CONTACT
A
Aurélie BAUQUET, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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