Clinical Trials /

Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Acute Leukemia After T Cell Depleted Allo-HSCT

NCT04959903

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04959903

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Acute Leukemia After T Cell Depleted Allo-HSCT
  • Official Title: A Phase I/II Study Evaluating the Safety and the Efficacy of SMART101 Injection to Accelerate Immune Reconstitution After T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric and Adult Patients With Acute Leukemia

Clinical Trial IDs

  • ORG STUDY ID: SI101-01
  • NCT ID: NCT04959903

Conditions

  • Leukemia, Acute

Interventions

DrugSynonymsArms
Allogeneic T cell progenitors, cultured ex-vivoSMART101Adult patients affected by acute leukemia (AML, ALL)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Adult patients affected by acute leukemia (AML, ALL)Experimental
  • Allogeneic T cell progenitors, cultured ex-vivo
Pediatric patients affected by acute leukemia (AML, ALL)Experimental
  • Allogeneic T cell progenitors, cultured ex-vivo

Eligibility Criteria

        Inclusion Criteria:

        Group A (adults):

          1. 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

          2. Patient eligible for an allogeneic HSCT

          3. Age ≥ 21y and clinical condition compatible with allogeneic bone marrow
             transplantation

          4. Karnofsky index ≥ 70%

          5. Patients with normal organ function

        Group B (pediatrics):

          1. 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

          2. Patient eligible for an allogeneic HSCT

          3. Age < 21y at the time of inclusion

          4. Absence of a matched sibling donor (MSD)

          5. Lansky ≥ 70% / Karnofsky ≥ 70%

          6. Patients with normal organ function

        Exclusion Criteria:

        Groups A and B:

          1. Planned use of an HLA matched CB (8/8 allele matched).

          2. Prior therapy with allogeneic stem cell transplantation

          3. Treatment with another cellular therapy within one month before inclusion
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Cumulative incidence of grade III-IV GvHD
Time Frame:100 days post-HSCT
Safety Issue:
Description:to evaluate the safety profile of the study drug

Secondary Outcome Measures

Measure:T cell immune reconstitution
Time Frame:up to Month 12 post-HSCT
Safety Issue:
Description:Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+ cells
Measure:Cumulative incidence of infections
Time Frame:Day 90, and Months 6, 12 and 24 post-HSCT
Safety Issue:
Description:
Measure:Non-relapse mortality (NRM)
Time Frame:Day 90, and Months 6, 12 and 24 post-HSCT
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Smart Immune SAS

Last Updated

July 13, 2021