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Trial Title:
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
NCT ID:
NCT05768035
Condition:
Hematological Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
AML, ALL, MSD
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Allogeneic T cell progenitors, cultured ex-vivo
Description:
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last
administration of cyclophosphamide
Arm group label:
Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT
Other name:
SMART101
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Investigator:
Last name:
Raynier Devillier, Pr
Email:
Principal Investigator
Facility:
Name:
Centre hospitalier universitaire de Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Investigator:
Last name:
Patrice Chevallier, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Hôpital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Investigator:
Last name:
Régis Peffault de Latour, Pr
Email:
Principal Investigator
Facility:
Name:
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Investigator:
Last name:
Anne Huynh, MD
Email:
Principal Investigator
Start date:
June 6, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Smart Immune SAS
Agency class:
Industry
Source:
Smart Immune SAS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768035
