Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-01-02 @ 3:27 AM
Study NCT ID:
NCT07044050
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of OT-C001 persistence after administering OT-C001.', 'timeFrame': 'From baseline (before lymphodepletion) to end of study treatment (within 14 days after the last dose of OT-C001).'}, {'measure': 'Changes in serum cytokine levels', 'timeFrame': 'From baseline (before lymphodepletion) to end of study treatment (within 14 days after the last dose of OT-C001)'}], 'primaryOutcomes': [{'measure': 'Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.', 'timeFrame': 'All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).'}], 'secondaryOutcomes': [{'measure': 'Antitumor activity characterized by objective response rate per Lugano criteria.', 'timeFrame': 'Tumor will be assessed at the end treatment cycles (3 and 6 weeks after the first dose), and every 12 weeks afterwards for up to of 2 years until progression of disease or starting new anti-cancer treatments.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B-cell Lymphoma With no Other Specification']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.\n\nParticipants will:\n\nReceive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment.\n\nParticipants need to visit the clinic or may be hospitalized according to the study plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy\n* with evaluable disease\n* with adequate biological parameters at baseline\n* ECOG performance status ≤1\n* life expectancy \\>3 months as assessed by the investigator\n\nExclusion Criteria:\n\n* Receive concomitantly any antitumor-directed drug therapy\n* Any vaccination with live virus vaccines before or during treatment\n* With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids\n* Major surgery within 3 weeks\n* With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement\n* Ongoing immune-related tocivities or adverse events grade \\>1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy\n* Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months\n* Primary or secondary immune deficiency\n* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment\n* Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV\n* Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months\n* Dementia or altered mental status that would prohibit informed consent\n* Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes'}, 'identificationModule': {'nctId': 'NCT07044050', 'briefTitle': 'A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emercell SAS'}, 'officialTitle': 'A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'C00101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Dose Level 1)', 'description': 'OT-C001 1 vial, weekly dosing', 'interventionNames': ['Biological: allogenic natural killer cells']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Dose Level 2)', 'description': 'OT-C001 3 vials, weekly dosing', 'interventionNames': ['Biological: allogenic natural killer cells']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort -1 (Sub Dose Level)', 'description': 'OT-C001 1/3 vial (100M)', 'interventionNames': ['Biological: allogenic natural killer cells']}], 'interventions': [{'name': 'allogenic natural killer cells', 'type': 'BIOLOGICAL', 'otherNames': ['OT-C001', 'NK-001'], 'description': 'OT-C001 will be administered by IV infusion weekly for at least 3 doses.', 'armGroupLabels': ['Cohort -1 (Sub Dose Level)', 'Cohort 1 (Dose Level 1)', 'Cohort 2 (Dose Level 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile LONONGO (POPKO)', 'role': 'CONTACT', 'email': 'c-popko@chu-montpellier.fr', 'phone': '+33 4 67 33 24 13'}, {'name': 'Guillaume Cartron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint-Eloi Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Erica Wang', 'role': 'CONTACT', 'email': 'e.wang@emercell.com', 'phone': '886 921 865 855'}, {'name': 'Bruno Piccolella', 'role': 'CONTACT', 'email': 'bruno.piccolella@onward-therapeutics.com', 'phone': '+33 6 12 97 73 68'}], 'overallOfficials': [{'name': 'Alain Herrera', 'role': 'STUDY_CHAIR', 'affiliation': 'Emercell SAS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emercell SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}