Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-31 @ 5:23 AM
Study NCT ID:
NCT06830733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007952', 'term': 'Leukemia, Plasma Cell'}], 'ancestors': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': '3 months after the first infusion', 'description': 'Overall response rate (ORR) during the initial 3 months after the first infusion (at least presenting a partial response according to the International Myeloma Working Group criteria).'}, {'measure': 'Rate of patients who develop cytokine release syndrome and/or neurological toxicity', 'timeFrame': '30 days after CARTBCMA administration', 'description': 'Rate of patients who develop cytokine release syndrome and/or neurological toxicity in the first 30 days after CARTBCMA administration, according to the criteria and grading defined in the international consensus document'}], 'secondaryOutcomes': [{'measure': 'Duration of response', 'timeFrame': 'From day 28 after infusion to study completion, an average of 24 months', 'description': 'Duration of response calculated from the time of first disease evaluation'}, {'measure': 'Response rates', 'timeFrame': 'During the first year after administration', 'description': 'Response rates'}, {'measure': 'Complete response rate', 'timeFrame': 'at 3, 6, and 12 months after the first infusion', 'description': 'Complete response rate'}, {'measure': 'Overall response rate', 'timeFrame': 'at 6, and 12 months after the first infusion', 'description': 'Overall response rate'}, {'measure': 'Time to complete response', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Time to complete response'}, {'measure': 'Time to best response', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Time to best response'}, {'measure': 'MRD negative rate in bone marrow', 'timeFrame': 'at 3, 6 12 and 24 months', 'description': 'MRD negative rate in bone marrow by flow cytometry'}, {'measure': 'Response rate of extramedullary disease', 'timeFrame': 'at 3, 6 and 12 months.', 'description': 'Response rate of extramedullary disease by PET-CT'}, {'measure': 'Progression-free survival', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'defined as the time between administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.'}, {'measure': 'Progression-free survival at 12 months after the first administration', 'timeFrame': '12 months', 'description': 'Progression-free survival at 12 months after the first administration, defined as the time elapsed between the administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.'}, {'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Overall survival, defined as the time between infusion of ARI0002h and death of the patient from any cause. Living patients will be censored at the time of last follow-up.'}, {'measure': 'Presence of infusion reactions', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Presence of infusion reactions, understood as the appearance of any of the following symptoms after the intravenous administration of CARTBCMA: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, rash or urticaria.'}, {'measure': 'Tumour lysis syndrome', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Tumour lysis syndrome'}, {'measure': 'Cytokine release syndrome', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Cytokine release syndrome. According to the criteria and grading defined in the international consensus document'}, {'measure': 'Neurological toxicity', 'timeFrame': 'through study completion, an average of 24 months', 'description': 'Neurological toxicity according to the criteria and grading defined in the international consensus document (Lee, Santomasso et al. 2019)'}, {'measure': 'Presence of prolonged cytopenias', 'timeFrame': 'between 4 weeks after infusion and study completion', 'description': 'Presence of prolonged cytopenias, defined as a grade 4 decrease in peripheral blood neutrophil or platelet counts for more than 4 weeks after infusion.'}, {'measure': 'Quality of life of patients', 'timeFrame': 'during the first year after infusion', 'description': 'Quality of life during the first year after infusion according to the Quality of life questionnaire 2008 EuroQol Group EQ-5D'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Plasma Cell']}, 'descriptionModule': {'briefSummary': 'Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL).\n\nThe study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months.\n\nThe primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG).\n2. Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "International Myeloma Working Group".\n3. ECOG Performance Status from 0 to 2\n4. Life expectancy greater than 3 months.\n5. Adequate venous access and absence of contraindications for lymphoapheresis.\n6. Patients who, after being informed, give their consent by signing the Informed Consent Document.\n7. Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion.\n\nExclusion Criteria:\n\n1. No previous treatments, except for induction therapy for primary plasma cell leukemia.\n2. Administration of any anti-BCMA therapy as part of induction\n3. Not having achieved at least a minimal response with induction treatment (IMWG criteria)\n4. Absolute lymphocyte count \\<0.1x109/L\n5. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).\n6. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.\n7. Active infection requiring treatment.\n8. Active HIV, HBV, or HCV infection.\n9. Uncontrolled medical illness\n10. Severe organ impairment that meets any of the following criteria: EF\\<40%, DLCO \\<40%, GFR \\<30 ml/min, bilirubin \\>3 times the upper limit of normality (unless due to Gilbert syndrome)\n11. Previous diagnosis of symptomatic AL amyloidosis,\n12. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase.\n13. Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\\* from the beginning of the study to completion of the study.\n14. Men who are unable or unwilling to use highly effective contraceptive methods\\* from the beginning of the study to completion of the study.\n15. Contraindication to receive lymphodepletive chemotherapy.'}, 'identificationModule': {'nctId': 'NCT06830733', 'acronym': 'GEM-PLASMACAR', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Phase II, Multicenter, Open-label, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of ARI0002h, a CAR-T Cell Against BCMA, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia', 'orgStudyIdInfo': {'id': '2024-515053-21-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARI0002h', 'description': 'ARI0002 will be administered intravenously in two doses. First dose will b e a fractionated infusion of three doses of the investigational medicinal product (day 0: 10% dose, day 3: 30% dose, day 7: 60% dose), and a second adminsitration as a single dose at 2 months after the first in those patients who have achieved at least a minimal response, have not presented PCL progression after the first infusion or serious complications after the first infusion.', 'interventionNames': ['Genetic: ARI0002h']}], 'interventions': [{'name': 'ARI0002h', 'type': 'GENETIC', 'description': '* Treatment with ARI0002h cells\n* Other names: CARTBCMA\\_J22.9-h:CD8TM:4-1BB:CD3. Adult differentiated autologous T cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory domain and the CD3z signalling domain that has been humanized.', 'armGroupLabels': ['ARI0002h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'contacts': [{'name': 'María Aranzazu Bermúdez Rodriguez', 'role': 'CONTACT', 'email': 'maranzazu.bermudez@scsalud.es', 'phone': '942 20 25 20'}], 'facility': 'Hospital Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28027', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Paula Rodríguez Otero', 'role': 'CONTACT', 'email': 'paurodriguez@unav.es', 'phone': '913 53 19 20'}], 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Rafael Alonso', 'role': 'CONTACT', 'email': 'rafaelalberto.alonso@salud.madrid.org', 'phone': '913 90 80 00'}], 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'contacts': [{'name': 'Valentín Cabañas', 'role': 'CONTACT', 'email': 'valentin.cabanas@gmail.com', 'phone': '968 36 95 00'}], 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'contacts': [{'name': 'Paula Rodríguez Otero', 'role': 'CONTACT', 'email': 'paurodriguez@unav.es', 'phone': '948 25 54 00'}], 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'contacts': [{'name': 'María Victoria Mateos', 'role': 'CONTACT', 'email': 'mvmateos@usal.es', 'phone': '923 29 11 00'}], 'facility': 'Complejo Asistencial Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Carlos Fernandez de Larrea', 'role': 'CONTACT', 'email': 'cfernan1@clinic.cat', 'phone': '+34932275400'}], 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Carlos Fernandez de Larrea, MD, PhD', 'role': 'CONTACT', 'email': 'cfernan1@clinic.cat', 'phone': '+34932775400'}, {'name': 'Maria Joyera', 'role': 'CONTACT', 'email': 'joyera@recerca.clinic.cat', 'phone': '+34932775400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}