Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 10:32 PM
Study NCT ID:
NCT05768035
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D052517', 'term': 'Multiple Sulfatase Deficiency Disease'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D052516', 'term': 'Sulfatidosis'}, {'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '* Phase I/II, open-label, dose-escalation, single arm, multicenter study.\n* This study will comprise two segments:\n\n * A phase I dose-escalation segment: Three (3) prespecified dose-levels of SMART101 will be evaluated in three consecutive cohorts of patients whatever the type of conditioning regimen the patients will receive before the HSCT to define the SMART101 recommended dose (RecD).\n * A phase II segment: once all patients from the dose-escalation segment have completed their "treatment period " and the SMART101 RecD has been defined, a total number of 34 patients will be enrolled at the RecD in the phase II segment of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Month 24 post-HSCT'}, {'measure': 'Disease-free Survival', 'timeFrame': 'Month 24 post-HSCT'}], 'primaryOutcomes': [{'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': 'CD4+ T cell count.', 'timeFrame': '100 days post-HSCT', 'description': 'to evaluate the efficacy of the study drug'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adverse events (AEs)', 'timeFrame': 'up to 24 months post-HSCT'}, {'measure': 'T cell immune reconstitution', 'timeFrame': 'up to 12 months post-HSCT', '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', 'timeFrame': 'Day 100, and Months 6 and 12 post-HSCT'}, {'measure': 'Non-relapse mortality (NRM)', 'timeFrame': 'Day 100, and Months 6, 12 and 24 post-HSCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML, ALL, MSD'], 'conditions': ['Hematological Malignancies']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.\n* Patients must be ≥ 18 years of age at the time of signing the ICF.\n* Patients must have a Karnofsky index ≥ 70%.\n* Patients must have a left ventricular ejection fraction of ≥40%.\n* Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.\n* Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.\n\nMain Exclusion Criteria:\n\n* Patients who have received prior allogeneic stem cell transplantation.\n* Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.\n* Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.'}, 'identificationModule': {'nctId': 'NCT05768035', 'briefTitle': 'Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smart Immune SAS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SI101-02'}}, 'armsInterventionsModule': {'armGroups': [{'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\n\n1. 1.5 x 106 CD7+ cells per kg of body weight\n2. 4.5 x 106 CD7+ cells per kg of body weight\n3. 9.0 x 106 CD7+ cells per kg of body weight\n\nSegment 2:\n\n2 cohorts of patients will be included in the study based on the type of conditioning regimen:\n\n* The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC).\n* The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC).\n* Enrollment of patients in each cohort will be done in parallel.', 'interventionNames': ['Biological: Allogeneic T cell progenitors, cultured ex-vivo']}], 'interventions': [{'name': 'Allogeneic T cell progenitors, cultured ex-vivo', 'type': 'BIOLOGICAL', 'otherNames': ['SMART101'], 'description': 'Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide', 'armGroupLabels': ['Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Raynier Devillier, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrice Chevallier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre hospitalier universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Régis Peffault de Latour, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Huynh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Frédéric LEHMANN, MD', 'role': 'CONTACT', 'email': 'frederic.lehmann@smart-immune.com', 'phone': '+32 (0) 492 46 23 55'}, {'name': 'Aurélie BAUQUET, PhD', 'role': 'CONTACT', 'email': 'aurelie.bauquet@smart-immune.com'}], 'overallOfficials': [{'name': 'Fabio CICERI, MD, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.R.C.C.S. Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smart Immune SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}