Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-01 @ 2:20 PM
Study NCT ID:
NCT03664635
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MB-CART20.1 Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I - Determination of the maximum tolerated dose (MTD)', 'timeFrame': 'until day 28 after infusion of MB-CART20.1', 'description': 'MTD is defined as the highest dose level at which \\< 33% of patients experience Dose Limiting Toxicity (DLT). Safety and toxicity assessment of MB-CART20.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.'}, {'measure': 'Phase II - Best overall response rate', 'timeFrame': '3 months after infusion of MB-CART20.1', 'description': 'Response (Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)) is defined according to Cheson criteria.'}], 'secondaryOutcomes': [{'measure': 'Phase I - Related safety and toxicity of MB-CART20.1', 'timeFrame': 'months 3, 6, 9 and 12 after infusion of MB-CART20.1', 'description': 'Per adverse events (AE) reporting classified according to CTCAE version 5.0.'}, {'measure': 'Phase I - Best overall response rate over 4 weeks and 3 months', 'timeFrame': '4 weeks and 3 months after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase I - Best overall response rate over 1 year', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase I - Occurrence of B-cell aplasia', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.'}, {'measure': 'Phase I - Phenotype and Persistence of MB-CART20.1', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.'}, {'measure': 'Phase II - Best overall response rate over 1 year', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase II - Overall response rate over 4 weeks and 3 months', 'timeFrame': '4 weeks and 3 months after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase II - Overall response rate over 1 year', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase II - Number of patients with CR, PR, SD and PD', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase II -Percentage of patients with CR, PR, SD and PD', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Response (CR, PR, SD and PD) is defined according to Cheson criteria.'}, {'measure': 'Phase II - Safety and toxicity assessment of MB-CART20.1', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Per adverse events (AE) reporting classified according to CTCAE version 5.0.'}, {'measure': 'Phase II - Occurrence of B-cell aplasia', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.'}, {'measure': 'Phase II - Phenotype and Persistence of MB-CART20.1', 'timeFrame': '1 year after infusion of MB-CART20.1', 'description': 'Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma", "Non-Hodgkin's Lymphoma", 'B-cell Lymphoma Refractory', 'B-cell Lymphoma Recurrent']}, 'descriptionModule': {'briefSummary': 'This trial is a phase I/II trial to assess safety, dose finding and feasibility of ex vivo generated MB-CART20.1 cells in patients with relapsed or refractory CD20 positive B-NHL.', 'detailedDescription': 'MB-CART20.1 consists of autologous Anti-CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in Non-Hodgkin-Lymphoma (NHL)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Refractory/relapsed CD20+ B-NHL (including malignant transformation like Richter's transformation) with no curative treatment option.\n* At least 18 years of age\n* Estimated life expectancy of more than 3 months\n* ECOG performance status (Eastern cooperative oncology group) of 0-2\n* Negative serological HBV (Hepatitis B virus) test, negative testing of HCVAb (Hepatitis C virus Antibody), negative HIV1/2 (Human immunodeficiency virus 1/2 ) test within 6 weeks prior to enrollment\n* No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential.\n* Signed and dated informed consent before conduct of any trial-specific procedure\n\nExclusion Criteria:\n\n* Participation in another interventional trial that could interact with this trial\n* Any evidence 0f CNS (Central nervous system) involvement\n* Known history or presence of clinically relevant CNS pathology\n* Patients with history of primary immunodeficiency,\n* Patients with any history of auto-immune induced condition such as those caused by checkpoint inhibitors, MEK inhibitors or BRAF inhibitors, for example pituitary hypophysitis must be excluded\n* Patients with Chronic Lymphocytic Leukemia unless suffering from malignant transformation\n* Active systemic fungal, viral or bacterial infection\n* Serious cardiac functional incapacity (class III or IV as defined by the New York Heart Association Classification)\n* Severe pulmonary disease (DLCO (Transfer factor of the lung for carbon monoxide) and/or FEV1 (Forced expiratory volume in 1 second) \\< 65%, dyspnea at rest)\n* Liver dysfunction as indicated by a total bilirubin, AST (Aspartate Aminotransferase), and ALT (Alanine aminotransferase) ≥ 2 the institutional ULN (Upper limit of normal) value, unless directly attributable to the patient's tumor\n* Creatinine clearance \\<50 ml/min calculated according to the modified formula of Cockcroft and Gault\n* Pregnant or lactating women\n* Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumor curatively treated by surgery) within the last 5 years before enrollment.\n* Medical condition requiring prolonged use of systemic corticosteroids (\\> 1 month)\n* Prior therapy with genetically modified substances\n* Use of anti-CD20 antibodies within 4 weeks before leukapheresis\n* Chemotherapy within 4 weeks prior to leukapheresis\n* Other treatment within 4 weeks or two half-lives, whichever is longer before MB-CART20.1 infusion. This pertains to immunomodulatory therapies such as checkpoint inhibitors because of the influence on the immune system\n* Concurrent systemic radiotherapy\n* Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment of related toxicities\n* Patients in which such medication is contraindicated for other reasons than hypersensitivity (e.g. live vaccines and fludarabine)\n* Patients in which trial related procedures are contraindicated as judged by the investigator, e.g. lumbar punctures for CSF (Cerebrospinal fluid) sampling\n* Patient's lack of accountability, inability to appreciate the nature, meaning and consequence of the trial and to formulate his/her own wishes correspondingly\n* Patients who have a relationship of dependence or employer employee relationship to the sponsor or the investigator\n* Committal to an institution on judicial or official order\n* Cerebral dysfunction, legal incapacity\n* Other investigational treatment within 4 weeks before IMP (Investigational Medicinal Product) infusion\n* Clinically relevant autoimmune diseases or history of autoimmune disease"}, 'identificationModule': {'nctId': 'NCT03664635', 'briefTitle': 'MB-CART20.1 Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miltenyi Biomedicine GmbH'}, 'officialTitle': 'A Phase I/II Safety, Dose Finding and Feasibility Trial of MB-CART20.1 in Patients with Relapsed or Resistant CD20 Positive B-NHL', 'orgStudyIdInfo': {'id': 'M-2016-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I - Safety Dose Level', 'description': 'In phase I three (3) + 3 patients will be treated with 1x10\\^5 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the preceding safety dose level', 'interventionNames': ['Biological: MB-CART20.1']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I - Dose Level 1', 'description': 'In phase I six (6) + 3 patients will be treated with 1x10\\^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 1', 'interventionNames': ['Biological: MB-CART20.1']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I - Dose Level 2', 'description': 'In phase I six (6) + 3 patients will be treated with 3x10\\^6 MB-CART20.1 cells per kg body weight administered intravenously as single dose in the dose level 2', 'interventionNames': ['Biological: MB-CART20.1']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II', 'description': 'The number of additional patients who will be treated with MB-CART20.1 cells in Phase II is depending on the number of evaluable patients treated with the maximum tolerated dose (MTD) level and the results in Part I', 'interventionNames': ['Biological: MB-CART20.1']}], 'interventions': [{'name': 'MB-CART20.1', 'type': 'BIOLOGICAL', 'otherNames': ['CD20-targeting CAR T Cells', 'Anti-CD20 CAR T cells'], 'description': 'MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in NHL', 'armGroupLabels': ['Phase I - Dose Level 1', 'Phase I - Dose Level 2', 'Phase I - Safety Dose Level', 'Phase II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne - Clinic for Internal Medicine I', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklikum Leipzig, AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Peter Borchmann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Köln'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miltenyi Biomedicine GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}