Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic T cell progenitors, cultured ex-vivo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT
- description
- Segment 1: 3 dose-level SMART101 cells/infusion 1. 1.5 x 106 CD7+ cells per kg of body weight 2. 4.5 x 106 CD7+ cells per kg of body weight 3. 9.0 x 106 CD7+ cells per kg of body weight Segment 2: 2 cohorts of patients will be included in the study based on the type of conditioning regimen: * The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC). * The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC). * Enrollment of patients in each cohort will be done in parallel.
- interventionNames
- Biological: Allogeneic T cell progenitors, cultured ex-vivo
Primary outcomes (2)
- measure
- Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.
- timeFrame
- 14 days post SMART101 infusion
- description
- To evaluate the safety of SMART101.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available