Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT05349266
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2022-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limited toxicity(DLT) observation in patient with NHL during dose escalation stage', 'timeFrame': '28 days', 'description': 'DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.'}, {'measure': 'Objective Response Rate in patient with NHL during dose expansion stage', 'timeFrame': '12 months', 'description': 'the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate during dose escalation stage and expansion stage', 'timeFrame': '12 months', 'description': 'the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment'}, {'measure': 'Duration of response(DOR) during dose escalation stage and expansion stage', 'timeFrame': '12 months', 'description': 'The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR)'}, {'measure': 'OS(overall survival) during dose escalation stage and expansion stage', 'timeFrame': '12 months', 'description': 'Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.'}, {'measure': 'Time to remission(TTR) during dose escalation stage and expansion stage', 'timeFrame': '12 months', 'description': 'Time to remission(TTR) is defined as the time from the date of ThisCART19A infusion until the date of first remission.'}, {'measure': 'Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages', 'timeFrame': '6 months', 'description': 'Track CAR T cells expansion in patients after infusion'}, {'measure': 'Analysis the change characteristics of cytokines and immune effect cells number during dose escalation and expansion stages', 'timeFrame': '3 months', 'description': 'Analysis the effect cells and cytokines in patient after infusion'}, {'measure': 'Analysis the severity and Incidence of Adverse Events in each dose level during dose expansion stage', 'timeFrame': '3 months', 'description': 'Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention'}, {'measure': 'Analysis the immunogenicity(anti-therapeutic antibody and neutralizing antibody) of CAR-T cells after infusion', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': 'This is a phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc.\n* Failing to autologous CAR-T therapy.\n* At least one available lesion to be assessed.\n* Good organ function during screening.\n* Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.\n\nExclusion Criteria:\n\n* Allergic to preconditioning measures.\n* Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.\n* Uncontrollable bacterial, fungal and viral infection during screening.\n* Patients had pulmonary embolism within 3 months prior to enrollment.\n* Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.\n* Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \\< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment.\n* Had big lesion(single lesion diameter ≥10 cm).\n* Bone marrow involvement≥5%.\n* Receive allogeneic hematopoietic stem cell transplantation less than 100 days.\n* Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor.\n* Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .\n* Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.\n* Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion."}, 'identificationModule': {'nctId': 'NCT05349266', 'briefTitle': 'Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': "Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cells Non-Hodgkin's Lymphoma(B-NHL) After Failure of Autologous CAR-T Therapy", 'orgStudyIdInfo': {'id': 'FT400-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ThisCART19A 2×10^6 cells/kg for dose level 1', 'description': 'Patients will receive 2×10\\^6 cells/kg of ThisCART19A', 'interventionNames': ['Biological: ThisCART19A']}, {'type': 'EXPERIMENTAL', 'label': 'ThisCART19A 3×10^6 cells/kg as dose level 2', 'description': 'Patients will receive 3×10\\^6 cells/kg of ThisCART19A', 'interventionNames': ['Biological: ThisCART19A']}, {'type': 'EXPERIMENTAL', 'label': 'Patients will receive 4×10^6 cells/kg as dose level 3', 'description': 'Patients will receive 4×10\\^6 cells/kg of ThisCART19A', 'interventionNames': ['Biological: ThisCART19A']}], 'interventions': [{'name': 'ThisCART19A', 'type': 'BIOLOGICAL', 'description': 'each patient will receive a dose level per body weight(kg) for only once.', 'armGroupLabels': ['Patients will receive 4×10^6 cells/kg as dose level 3', 'ThisCART19A 2×10^6 cells/kg for dose level 1', 'ThisCART19A 3×10^6 cells/kg as dose level 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, Doctor', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ming Ming Zhang, Doctor', 'role': 'CONTACT', 'email': 'mingmingzhang@zju.edu.cn', 'phone': '13656674208'}], 'overallOfficials': [{'name': 'He Huang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First hospital affiliated Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President/Proffessor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}