Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT04323657
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2020-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2020-03-22', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish the recommended phase 2 dose (RP2D) for the NHL and ALL indications according to the observed adverse events, including potential dose-limiting toxicities (DLT).', 'timeFrame': 'DLTs within 28 days post-treatment'}, {'measure': 'To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R NHL as determined by overall response rate (ORR)', 'timeFrame': 'ORR at 3 months for NHL patients at 3 months'}, {'measure': 'To evaluate the efficacy of autologous genetically modified TC-110 T cells in adult patients with R/R ALL as determined by overall response rate and Minimum Residual Disease (MRD) negativity rates', 'timeFrame': 'ORR rate and MRD negativity rate for ALL patients at 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Hodgkin Lymphoma', 'Acute Lymphoblastic Leukemia', 'Diffuse Large B Cell Lymphoma', 'Primary Mediastinal Large B Cell Lymphoma', 'Mantle Cell Lymphoma', 'Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.\n\nThis is a Phase 1/2 open-label study to evaluate the safety of autologous genetically engineered TC-110 T cells in patients with aggressive NHL (DLBCL, PMBCL, TFL), high-risk indolent NHL (including MCL), or adult ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is \\> 18 years of age at the time the Informed Consent is signed\n* Patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and LTFU\n* Histologically confirmed NHL or ALL\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol\n* Patient must be fit for leukapheresis and have adequate venous access for cell collection\n* Patient must have evidence of CD19 expression\n* Prior CD19-directed CAR T therapy is allowed'}, 'identificationModule': {'nctId': 'NCT04323657', 'briefTitle': 'TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCR2 Therapeutics'}, 'officialTitle': 'Phase 1/2 Trial of TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Acute Lymphoblastic Leukemia (ALL)', 'orgStudyIdInfo': {'id': 'TCR2-19-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1', 'description': 'The Phase 1 portion of the study will proceed according to a standard 3 + 3 dose escalation schema. Patients will be enrolled into 3 cohorts based on disease: NHL cohort, low tumor burden ALL cohort, and high tumor burden ALL cohort.', 'interventionNames': ['Drug: TC-110 T Cells', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'The phase 2 portion of the study will evaluate the efficacy of TC-110 T cells administered at the RP2D, preceded by a lymphodepleting regimen.', 'interventionNames': ['Drug: TC-110 T Cells', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'TC-110 T Cells', 'type': 'DRUG', 'description': 'TC-110 T Cells', 'armGroupLabels': ['Phase 1', 'Phase 2']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Flu/Cy Lymphodepletion', 'armGroupLabels': ['Phase 1', 'Phase 2']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Flu/Cy Lymphodepletion', 'armGroupLabels': ['Phase 1', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Clinical', 'role': 'STUDY_CHAIR', 'affiliation': 'TCR2 Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCR2 Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}