Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Acute Leukemia After T Cell Depleted Allo-HSCT
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with relapsed/refractory acute leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adult patients affected by acute leukemia (AML, ALL)
|
Biological: Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors at [Day 4-Day 10] after T cell depleted allogeneic HSCT
Other Names:
|
| Experimental: Pediatric patients affected by acute leukemia (AML, ALL)
|
Biological: Allogeneic T cell progenitors, cultured ex-vivo
Injection of T cell progenitors at [Day 4-Day 10] after T cell depleted allogeneic HSCT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cumulative incidence of grade III-IV GvHD [100 days post-HSCT]
to evaluate the safety profile of the study drug
- Occurrence of adverse events related to SMART101 [100 days post-HSCT]
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
- CD4+ T cell count [100 days post-HSCT]
to evaluate the efficacy of the study drug
Secondary Outcome Measures
- T cell immune reconstitution [up to Month 12 post-HSCT]
Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+ cells
- Cumulative incidence of infections [Day 90, and Months 6, 12 and 24 post-HSCT]
- Non-relapse mortality (NRM) [Day 90, and Months 6, 12 and 24 post-HSCT]
Other Outcome Measures
- Overall Survival (OS) [Month 24 post-HSCT]
- Disease-free Survival [Month 24 post-HSCT]
Eligibility Criteria
Criteria
Inclusion Criteria:
Group A (adults):
- Adult patients affected by acute leukemia (AML, ALL) defined as:
-
Acute Myeloid Leukemia (AML):
-
High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities
-
Chemo-refractory relapse (MRD+)
-
≥ CR2
-
Acute Lymphoblastic Leukemia (ALL):
-
Chemo-refractory relapse (MRD+)
-
High risk in CR1; Philadelphia (like) or any poor risk feature
-
≥ CR2
-
Patient eligible for an allogeneic HSCT
-
Age ≥ 21y and clinical condition compatible with allogeneic bone marrow transplantation
-
Karnofsky index ≥ 70%
-
Patients with normal organ function
Group B (pediatrics):
- Pediatric patients affected by acute leukemia (AML, ALL) defined as:
-
Acute Myeloid Leukemia (AML):
-
High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities,
-
Chemo-refractory relapse (MRD+)
-
≥ CR2
-
Acute Lymphoblastic Leukemia (ALL):
-
Chemo-refractory relapse (MRD+)
-
High risk in CR1; Philadelphia (like) or any poor risk feature
-
≥ CR2
-
Patient eligible for an allogeneic HSCT
-
Age < 21y at the time of inclusion
-
Absence of a matched sibling donor (MSD)
-
Lansky ≥ 70% / Karnofsky ≥ 70%
-
Patients with normal organ function
Exclusion Criteria:
Groups A and B:
-
Planned use of an HLA matched CB (8/8 allele matched).
-
Prior therapy with allogeneic stem cell transplantation
-
Treatment with another cellular therapy within one month before inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center (MSKCC) | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Smart Immune SAS
Investigators
- Principal Investigator: Jaap-Jan BOELENS, MD, PhD, Memorial Sloan Kettering Cancer Center (MSKCC)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SI101-01