Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07410494
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
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'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label due to the nature of personalized antigen assignment and cell product differences'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, type, and severity of adverse events (AEs), graded by CTCAE v5.0', 'timeFrame': '28 DAYS'}, {'measure': 'Incidence of Dose-Limiting Toxicities (DLTs)', 'timeFrame': '28 DAYS'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) (RECIST 1.1)', 'timeFrame': '12 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-NK', 'Solid tumor', 'Dual-target CAR', 'ctDNA', 'CAR-T', 'Breast cancer', 'Non-small cell lung cancer (NSCLC)', 'Colorectal cancer (CRC)', 'Prostate cancer', 'Pancreatic ductal adenocarcinoma (PDAC)', 'Ovarian, fallopian tube, and primary peritoneal cancers', 'Glioblastoma and other high-grade gliomas', 'Melanoma', 'Acute myeloid leukemia (AML)', 'Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma', 'Multiple myeloma (especially relapsed/refractory)', 'Liver cancer (hepatocellular carcinoma, HCC)'], 'conditions': ['Cancer', 'Breast Cancer', 'Non-Small Cell Lung Cancer (NSCLC)', 'Colorectal Cancer (Locally Advanced or Metastatic)', 'Prostate Cancer - Recurrent', 'Pancreatic Ductal Adenocarcinoma (PDAC)', 'Ovarian Cancer', 'Glioblastoma', 'Melanoma (Skin Cancer)', 'Acute Myeloid Leukemia (AML)', 'Non Hodgkin Lymphoma', 'Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma', 'Liver Cancer']}, 'descriptionModule': {'briefSummary': 'This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and/or liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.', 'detailedDescription': 'This is an open-label, biomarker-driven adoptive cell therapy study.\n\nScreening / Target Selection (Precision Step):\n\nParticipants undergo tumor antigen profiling using:\n\nTissue biopsy (preferred when safely feasible), and/or Liquid biopsy (e.g., circulating tumor DNA plus circulating tumor cells/exosome protein assay, as available in the platform).\n\nAntigen profiling determines eligibility and assigns participants to:\n\nSingle-target CAR-NK if one antigen meets positivity thresholds, or Dual-target CAR-NK if two antigens meet thresholds or if heterogeneity is suspected.\n\nPre-specified target menu :\n\nTROP2, Mesothelin (MSLN), B7-H3 (CD276), HER2, EGFR, GD2, Claudin18.2, GPC3, PSMA ("Target menu" can be expanded in amendments.)\n\nCell Source / Manufacturing Concept:\n\nNK cells are obtained from a healthy allogeneic donor (unrelated or partially matched per site policy).\n\nDonor NK cells are collected by leukapheresis, activated/expanded, and genetically modified to express:\n\na single CAR (Arm A) or a dual CAR / dual-target construct (Arm B). Final product is cryopreserved and released after sterility/identity/potency testing.\n\nConditioning \\& Treatment:\n\nParticipants receive lymphodepleting chemotherapy followed by CAR-NK infusion(s). Many CAR-NK solid-tumor trials use conditioning regimens such as fludarabine and cyclophosphamide before infusion.\n\nOptional cytokine support (e.g., low-dose IL-2) may be used per protocol to support NK persistence, consistent with approaches used in some CAR-NK studies.\n\nFollow-up:\n\nIntensive safety monitoring during the first 28 days. Tumor imaging at protocol-defined intervals. Correlative studies including CAR-NK persistence and ctDNA dynamics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and/or liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets "positive" threshold\n* Arm B: ≥2 antigens meet "positive" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07410494', 'acronym': 'SELECT-CAR-NK', 'briefTitle': 'Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Essen Biotech'}, 'officialTitle': 'A Phase 1/2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and/or Liquid Biopsy Profiling in Participants With Relapsed/Refractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)', 'orgStudyIdInfo': {'id': 'EB-CARNK-S002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Target Antigen-Selected CAR-NK', 'description': 'Participants whose profiling identifies one dominant actionable antigen.', 'interventionNames': ['Biological: EB-SELECT Single-Target CAR-NK Cells']}, {'type': 'EXPERIMENTAL', 'label': 'Dual-Target Antigen-Selected CAR-NK', 'description': 'Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity.', 'interventionNames': ['Biological: Dual-Target Antigen-Selected CAR-NK']}], 'interventions': [{'name': 'EB-SELECT Single-Target CAR-NK Cells', 'type': 'BIOLOGICAL', 'otherNames': ['Lymphodepleting Chemotherapy', 'Fludarabine', 'Cyclophosphamide', 'IL-2'], 'description': 'Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.', 'armGroupLabels': ['Single-Target Antigen-Selected CAR-NK']}, {'name': 'Dual-Target Antigen-Selected CAR-NK', 'type': 'BIOLOGICAL', 'otherNames': ['EB-SELECT Dual-Target CAR-NK Cells', 'Fludarabine', 'Cyclophosphamide', 'IL-2'], 'description': 'Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.', 'armGroupLabels': ['Dual-Target Antigen-Selected CAR-NK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '086-373', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'SAMI XI, MD', 'role': 'CONTACT', 'email': 'SFM@districtonehospital.com', 'phone': '+14012275001'}], 'facility': 'District One Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Rhoda M Smith, PHD', 'role': 'CONTACT', 'email': 'clinical-trials@essen-biotech.com', 'phone': '+12077706670'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essen Biotech', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}