Evaluating SMART101 for immune recovery in blood cancer patients after stem cell transplant
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
This study is testing a new treatment called SMART101 to see if it can help blood cancer patients recover their immune systems faster after a stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Smart Immune SAS Industry-sponsored |
| Drugs / interventions | cyclophosphamide |
| Locations | 4 sites (Marseille and 3 other locations) |
| Trial ID | NCT05768035 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of SMART101, a treatment involving Human T Lymphoid Progenitors (HTLP), to enhance immune recovery in adult patients with hematological malignancies following haploidentical hematopoietic stem cell transplantation (HSCT) combined with post-transplant cyclophosphamide. The study will involve administering allogeneic T cell progenitors that are cultured ex-vivo to eligible participants. The trial is designed to determine how well this intervention can support patients' immune systems during recovery after transplantation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS) who are eligible for haploidentical HSCT.
Not a fit: Patients who have previously undergone allogeneic stem cell transplantation or those who have received other cellular therapies or investigational agents shortly before the SMART101 infusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve immune reconstitution and overall recovery for patients undergoing stem cell transplantation for blood cancers.
How similar studies have performed: While this approach is innovative, there is limited data on the success of similar interventions, making this study a potentially novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille and 3 other locations
- Institut Paoli Calmettes — Marseille, France (Recruiting)
- Centre hospitalier universitaire de Nantes — Nantes, France (Recruiting)
- Hôpital Saint-Louis — Paris, France (Recruiting)
- CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Fabio CICERI, MD, Pr. — I.R.C.C.S. Ospedale San Raffaele
- Study coordinator: Frédéric LEHMANN, MD
- Email: frederic.lehmann@smart-immune.com
- Phone: +32 (0) 492 46 23 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.