Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05768035 | Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide | PHASE1 | RECRUITING | 40 | — | — | Jun 6, 2023 | Jul 1, 2026 | Sep 25, 2023 | 4 | France |
| NCT04959903 | Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT | PHASE1 | RECRUITING | 36 | — | — | Mar 31, 2022 | May 1, 2027 | Mar 6, 2023 | 1 | United States |
To evaluate the safety of SMART101.
to evaluate the efficacy of the study drug
to evaluate the safety profile of the study drug
Number of adverse events and serious adverse events related to SMART101 tabulated for each dose and by age group to evaluate the safety profile of the study drug
to evaluate the efficacy of the study drug
| Arm | Type | Description |
|---|---|---|
| Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT | EXPERIMENTAL | 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. |
| Adult patients affected by hematological malignancies | EXPERIMENTAL | Adult patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) or myelodysplastic syndrome eligible for a T depleted allogeneic HSCT |
| Pediatric patients affected by hematological malignancies | EXPERIMENTAL | Pediatric patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) eligible for a T depleted allogeneic HSCT |
| Name | Type | Description |
|---|---|---|
| Allogeneic T cell progenitors, cultured ex-vivo | BIOLOGICAL | Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide |
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 ...