Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 7:38 AM
Study NCT ID:
NCT06120166
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': 'MTD will be determined based on DLTs observed during the first 28 days of study treatment.', 'description': 'Determine the Maximal Tolerable Dose(MTD)'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Within 3 months following infusion of Meta10-19', 'description': 'Measure Tumor response rate (including CR and PR)'}], 'secondaryOutcomes': [{'measure': 'Concentration of CAR-T cells', 'timeFrame': 'Up to 12 months after CAR-T treatment', 'description': 'Concentration of CAR-T cells measured by Flow cytometry after CAR-T infusion'}, {'measure': 'Pharmacodynamics of CAR-T cells', 'timeFrame': 'Up to 28 days after infusion', 'description': 'Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meta10-19', 'CAR-T Cells Therapy', 'r/r DLBCL'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma', 'detailedDescription': 'This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19+ Diffuse Large B-Cell Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products.\n\n1. Main research objectives:\n\n To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r DLBCL.\n2. Secondary research objectives:\n\n 1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion.\n 2. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient or his/her guardian voluntarily signed the informed consent\n* Adult Patients clinical diagnosis of relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included)\n\nDefinition of refractory:\n\n1. No response to the last treatment, including:\n\n The best response to the last treatment was PD, or ; The best response to the last treatment was SD and the duration was not more than 6 months after the last dose.\n2. Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including:\n\nDisease progression or recurrence within 12 months or less (recurrence must be confirmed by biopsy) after ASCT treatment, or; Patients accept remedial treatment after ASCT must have no response or relapse after the last treatment\n\n* Patients who had previously received ≥2 lines therapy including at least:\n\n 1. A chemotherapy regimen containing anthracyclines\n 2. For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL.\n* Patients with double-strike and triple-strike lymphoma who do not respond to second-line treatment, where double-strike/triple-strike is defined as:\n\nDetection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or/and BCL-6 gene translocation by chromosome or FISH technology.\n\n* CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection)\n* At least one measurable lesion at baseline, according to the initial assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition)\n* Expected survival time greater than 12 weeks\n* The baseline ECOG score was 0 or 1\n* Organ function:\n\n 1. Kidney function is defined as:\n\n Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m/ min/1.73m2; \\[eGFR=186×(age)-0.203×SCr- 1. 154(mg/dl), for females, the result was ×0.742\\]\n 2. Liver function is defined as:\n\n ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg/dl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included\n 3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment.\n* Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45%\n* Patients using the following drugs must meet the following conditions:\n\n 1. Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \\<6-12mg/mm2/ day\n 2. Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed\n 3. Anti-proliferative therapy in addition to preconditioning chemotherapy 2 weeks prior to Meta10-19 infusion\n 4. Treatment for CNS disease must be stopped 1 week before Meta10- 19 infusion (e.g., intrathecal methotrexate)\n* The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR T cell therapy\n* Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo\n\nExclusion Criteria:\n\n* Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* Patients with history of allogeneic hematopoietic stem cell transplantation\n* Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion\n* Patients who participated in other clinical trials within 30 days prior to enrollment\n* Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \\>1000 copies/ml) or hepatitis C (HCV RNA positive)\n* Patients with HIV antibody positive or treponema pallidum antibody positive\n* Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19infusion)\n* Patients with unstable angina pectoris and/or myocardial infarction within 6 months prior to enrollment\n* Patients with history of other malignancies, but the following conditions can be enrollment:\n\n 1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent);\n 2. Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent\n 3. The primary malignancy has been completely resected and in complete remission for ≥5 years\n* Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive)\n* Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);\n* Other conditions that the investigator considered should not be enrolled in this clinical study, such as poor compliance."}, 'identificationModule': {'nctId': 'NCT06120166', 'briefTitle': 'Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r/r DLBCL Clinical Research', 'orgStudyIdInfo': {'id': 'Meta10-19-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of Metabolically Armed CD19 CAR-T cells', 'description': 'Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. A dose of metabolically armed CD19 CAR-T cells will be infused on day 0.', 'interventionNames': ['Drug: Metabolically Armed CD19 CAR-T cells']}], 'interventions': [{'name': 'Metabolically Armed CD19 CAR-T cells', 'type': 'DRUG', 'otherNames': ['Meta10-19'], 'description': 'Each subject receive metabolically armed CD19 CAR-T cells by intravenous infusion', 'armGroupLabels': ['Administration of Metabolically Armed CD19 CAR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '86-15957162012'}, {'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yongxian Hu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Mingming Zhang', 'role': 'CONTACT', 'email': 'mingmingzhang@zju.edu.cn', 'phone': '86-13656674208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Huang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leman Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}