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Allogeneic T cell progenitors, cultured ex-vivo · 2 trials · 1 indication
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 ...
Allogeneic T cell progenitors, cultured ex-vivo, also known as SMART101, is an investigational cell therapy being studied for the treatment of hematological malignancies. It is currently in Phase 1 clinical trials for patients with these blood cancers, particularly after T cell depleted or haploidentical hematopoietic stem cell transplantation.
Allogeneic T cell progenitors, cultured ex-vivo is a cell therapy that involves the infusion of cultured T cell progenitors. The specific molecular target is not disclosed in the available information, but the therapy is designed to restore or enhance T cell immunity in patients with hematological malignancies following stem cell transplantation.
Allogeneic T cell progenitors, cultured ex-vivo is being developed by MeiraGTx Holdings plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol MGTX. The company is advancing this investigational therapy through Phase 1 clinical development.
Allogeneic T cell progenitors, cultured ex-vivo is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. Two Phase 1 trials are currently recruiting patients to evaluate its safety and efficacy in hematological malignancies.
Allogeneic T cell progenitors, cultured ex-vivo is being studied in two Phase 1 clinical trials. NCT04959903 is evaluating the therapy in pediatric and adult patients with hematological malignancies after T cell depleted allo-HSCT in the United States. NCT05768035 is studying it in adult patients after haploidentical HSCT with post-transplant cyclophosphamide in France.
Yes, Allogeneic T cell progenitors, cultured ex-vivo is also known as SMART101. The two names refer to the same investigational cell therapy being developed by MeiraGTx Holdings plc for the treatment of hematological malignancies.