Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT04662294
Status:
RECRUITING
Last Update Posted:
2021-11-04
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-12-05', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Baseline up to 28 days after CD70 targeted CAR T-cells infusion', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years after CD70 targeted CAR T-cells infusion', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Acute Myeloid Leukemia (AML), Overall response rate (ORR)', 'timeFrame': 'At Month 1, 3, 6, 12, 18 and 24', 'description': 'Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24'}, {'measure': 'AML, Overall survival (OS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to death or the last visit'}, {'measure': 'AML, Event-free survival (EFS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit'}, {'measure': "Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)", 'timeFrame': 'At Month 1, 3, 6, 12, 18 and 24', 'description': 'Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24'}, {'measure': 'NHL, Overall survival (OS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to death or the last visit'}, {'measure': 'NHL, Event-free survival (EFS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse,'}, {'measure': 'Multiple myeloma (MM), Overall response rate (ORR)', 'timeFrame': 'At Month 1, 3, 6, 12, 18 and 24', 'description': 'Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24'}, {'measure': 'MM, Overall survival (OS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to death or the last visit'}, {'measure': 'MM, Event-free survival (EFS)', 'timeFrame': 'Up to 2 years after CD70 CAR-T cells infusion', 'description': 'From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse'}, {'measure': 'Quality of life', 'timeFrame': 'At Baseline, Month 1, 3, 6, 9 and 12', 'description': 'Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \\[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12'}, {'measure': 'Activities of Daily Living (ADL) score', 'timeFrame': 'At Baseline, Month 1, 3, 6, 9 and 12', 'description': 'Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \\[max score: 100, min score: 0, higher scores mean a better outcome\\] at Baseline, Month 1, 3, 6, 9 and 12'}, {'measure': 'Instrumental Activities of Daily Living (IADL) score', 'timeFrame': 'At Baseline, Month 1, 3, 6, 9 and 12', 'description': 'Assessment of Instrumental Activities of Daily Living (IADL) scale \\[max score: 56, min score: 14, higher scores mean a worse outcome\\] at Baseline, Month 1, 3, 6, 9 and 12'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) score', 'timeFrame': 'At Baseline, Month 1, 3, 6, 9 and 12', 'description': 'Assessment using Hospital Anxiety and Depression Scale (HADS) \\[max score: 42, min score: 0, higher scores mean a worse outcome\\] at Baseline, Month 1, 3, 6, 9 and 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR T-cell therapy', 'CD70', 'Acute Myeloid Leukemia', "Non-Hodgkin's lymphoma", 'Multiple Myeloma'], 'conditions': ['Acute Myeloid Leukemia', "Non-hodgkin's Lymphoma", 'Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '37093350', 'type': 'DERIVED', 'citation': 'Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.'}, {'pmid': '35468680', 'type': 'DERIVED', 'citation': 'Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.'}]}, 'descriptionModule': {'briefSummary': 'A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases', 'detailedDescription': 'This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria only for AML:\n\n1. Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);\n2. Relapsed or refractory CD70+ AML (meeting one of the following conditions):\n\n 1. CR not achieved after standardized chemotherapy;\n 2. CR achieved following the first induction, but CR duration is less than 12 months;\n 3. Ineffectively after first or multiple remedial treatments;\n 4. 2 or more relapses;\n3. The number of primordial cells in bone marrow is \\> 5% (by morphology), and/or \\> 0.01% (by flowcytometry);\n4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;\n5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n7. Estimated survival time ≥ 3 months;\n8. ECOG performance status 0 to 2;\n9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.\n\nInclusion criteria only for NHL:\n\n1. No gender and age limit;\n2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);\n3. Relapsed or refractory CD70+ NHL (meeting one of the following conditions):\n\n 1. No response or relapse after second-line or above chemotherapy regimens;\n 2. Primary drug resistance;\n 3. Relapse after auto-HSCT;\n4. At least one assessable tumor lesion per Lugano 2014 criteria\n\nInclusion criteria only for MM:\n\n1. Histologically confirmed diagnosis of CD70 multiple myeloma (MM)：\n\n 1. According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma\n 2. Cases with recurrent positive minimal residual disease;\n 3. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.\n2. No gender and age limit;\n3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;\n4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;\n5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;\n6. Estimated survival time ≥ 3 months;\n7. ECOG performance status 0 to 2;\n8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.\n\nCommon inclusion criteria :\n\n1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;\n2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n4. Estimated survival time ≥ 3 months;\n5. ECOG performance status 0 to 2;\n6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent -\n\nExclusion Criteria:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Active infection of hepatitis B virus or hepatitis C virus;\n6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;\n7. Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies;\n8. Creatinine \\>2.5mg/dl, or ALT / AST\\>3 times of normal amounts, or bilirubin\\>2.0 mg/dl;\n9. Other uncontrolled diseases that were not suitable for this trial;\n10. Patients with HIV infection;\n11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. -'}, 'identificationModule': {'nctId': 'NCT04662294', 'briefTitle': 'CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases', 'orgStudyIdInfo': {'id': 'CD70-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-ALL', 'interventionNames': ['Biological: CD70 CAR T-cells']}, {'type': 'EXPERIMENTAL', 'label': 'T-NHL', 'interventionNames': ['Biological: CD70 CAR T-cells']}, {'type': 'EXPERIMENTAL', 'label': 'AML', 'interventionNames': ['Biological: CD70 CAR T-cells']}], 'interventions': [{'name': 'CD70 CAR T-cells', 'type': 'BIOLOGICAL', 'otherNames': ['CD70 CAR-T cells injection'], 'description': 'Each subject receive CD70 CAR T-cells by intravenous infusion', 'armGroupLabels': ['AML', 'T-ALL', 'T-NHL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', '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': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, PhD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '86-15957162012'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}