Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06119256
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-10-21', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'Percentage of participants with adverse events.'}], 'secondaryOutcomes': [{'measure': 'Changes of EBV-DNA copies number', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'Quantitative PCR will be used to determine viral copy numbers in peripheral blood.'}, {'measure': 'Persistence of EBV-TCR-T cells', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'Quantitative PCR using primers specific for the gene encoding EBV-TCR will be used to determine the number of circulating EBV-TCR-T cells in peripheral blood post infusion.'}, {'measure': 'Dose-limiting toxicity', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Toxic effects considered by the investigators to be related to the EBV-TCR-T'}, {'measure': 'Maximum tolerated dose', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'The highest dose of DLT was seen in 1/6 of the subjects'}, {'measure': 'The proportion of EBV-DNA negative patients', 'timeFrame': '180 days after EBV-TCR-T treatment', 'description': 'The proportion of patients EBV-DNA negative after EBV-TCR-T treatment'}, {'measure': 'The time to EBV-DNA negative', 'timeFrame': '180 days after EBV-TCR-T treatment', 'description': 'The time from the start of therapy to EBV-DNA negative detected'}, {'measure': 'The time to response', 'timeFrame': '180 days after EBV-TCR-T treatment', 'description': 'The time from the start of therapy to the time when patients firstly achieve complete remission or partial remission'}, {'measure': 'The duration of response', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'The time from the patients firstly achieve complete remission or partial remission to progression of disease'}, {'measure': 'The incidence of EBV-PTLD', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'The incidence of EBV-PTLD after EBV-TCR-T treatment'}, {'measure': 'The overall response rate to EBV-TCR-T treatment', 'timeFrame': '28,90,180,365,730 days after EBV-TCR-T treatment', 'description': 'The overall response rate to EBV-TCR-T treatment'}, {'measure': 'The complete response rate to EBV-TCR-T treatment', 'timeFrame': '28,90,180,365, and 730 days after EBV-TCR-T treatment', 'description': 'The complete response rate to EBV-TCR-T treatment'}, {'measure': 'The incidence of EBV reactivation after EBV-TCR-T treatment', 'timeFrame': '1 year after EBV-TCR-T treatment', 'description': 'The incidence of EBV reactivation after EBV-TCR-T treatment'}, {'measure': 'Maximum Plasma Concentration (Cmax) of EBV-TCR-T cells', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of EBV-TCR-T cells', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation'}, {'measure': 'Half life time (T1/2) of EBV-TCR-T cells', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation'}, {'measure': 'Concentration levels of cytokines', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Concentration levels of cytokines (IL-2, IL-6, IL-10, TNF-α, IFN-γ)'}, {'measure': 'Concentration levels of CRP', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Pharmacokinetics of EBV-TCR-T cells'}, {'measure': 'Concentration levels of ferritin', 'timeFrame': '28 days after EBV-TCR-T treatment', 'description': 'Pharmacokinetics of EBV-TCR-T cells'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EBV infection', 'allogenic HSCT'], 'conditions': ['EBV Infection After Allogenic HSCT']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.', 'detailedDescription': 'EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\\*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10\\^5/kg to 1×10\\^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 14-75 years, gender unlimited.\n* Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.\n* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\\<16y).\n* TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\\~4) × 10\\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.\n\nExclusion Criteria:\n\n* Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.\n* Patients with severe kidney disease (Cr \\> 3×normal value), liver damage (TBIL \\>2.5×upper limit of normal value, ALT and AST \\> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.\n* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.\n* Have other malignancies.\n* Have relapsed and uncontrolled hematologic malignancies.\n* Serologically positive for HIV-Ab or TAP-ab.\n* Pregnant or lactating women.\n* Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.\n* Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.'}, 'identificationModule': {'nctId': 'NCT06119256', 'briefTitle': 'Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT', 'orgStudyIdInfo': {'id': 'S2022-083-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBV-TCR-T cells', 'description': 'Phase 1 trail:\n\nThe patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\\^5/kg to 1×10\\^6/kg EBV-TCR-T cells per dose.\n\nPhase 2 trail:\n\nAccording to the PK and response data, the dose escalation phase will be carried out.', 'interventionNames': ['Biological: EBV-TCR-T cells']}], 'interventions': [{'name': 'EBV-TCR-T cells', 'type': 'BIOLOGICAL', 'description': 'The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\\^5/kg to 1×10\\^6/kg EBV-TCR-T cells per dose.', 'armGroupLabels': ['EBV-TCR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daihong Liu, Doctor', 'role': 'CONTACT', 'email': 'daihongrm@163.com', 'phone': '86-13681171597'}, {'name': 'Liping Dou, Doctor', 'role': 'CONTACT', 'email': 'lipingruirui@163.com', 'phone': '86-13681207138'}, {'name': 'Daihong Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Daihong Liu, Doctor', 'role': 'CONTACT', 'email': 'daihongrm@163.com', 'phone': '+86 18301339032'}, {'name': 'Liping Dou, Doctor', 'role': 'CONTACT', 'phone': '+86 13681207138'}], 'overallOfficials': [{'name': 'Daihong Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Daihong Liu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}