Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04657861
Status:
RECRUITING
Last Update Posted:
2022-05-09
First Post:
2020-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2027-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-12-05', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Baseline up to 28 days after APRIL 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': 'Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Multiple Myeloma (MM), Overall response rate (ORR)', 'timeFrame': 'At Month 1, 3, 6, 12, 18 and 24', 'description': 'Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 1, 3, 6, 12, 18 and 24'}, {'measure': 'MM, Overall survival (OS)', 'timeFrame': 'Up to 2 years after APRIL CAR-T cells infusion', 'description': 'From the first infusion of APRIL CAR-T cells to death or the last visit'}, {'measure': 'MM, Event-free survival (EFS)', 'timeFrame': 'Up to 2 years after APRIL CAR-T cells infusion', 'description': 'From the first infusion of APRIL 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': 'Quality of life including sports activity', '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': ['Multiple Myeloma', 'CAR T-cell therapy', 'BCMA/TACI positive'], 'conditions': ['Multiple Myeloma in Relapse', 'Multiple Myeloma, Refractory']}, 'descriptionModule': {'briefSummary': 'A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma', 'detailedDescription': 'This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM)：\n\n 1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression;\n 2. Relapsed after hematopoietic stem cell transplantation;\n 3. Cases with recurrent positive minimal residual disease;\n 4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.\n2. Male or female aged 18-75 years;\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\nExclusion Criteria:\n\nSubjects with any of the following exclusion criteria were not eligible for this trial:\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 in haled steroids;\n7. Previously treated with any CAR-T cell product or other genetically modified 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': 'NCT04657861', 'briefTitle': 'APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'APRIL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of APRIL CAR T-cells', 'description': 'Each subject receive APRIL CAR T-cells by intravenous infusion', 'interventionNames': ['Drug: APRIL CAR-T cells']}], 'interventions': [{'name': 'APRIL CAR-T cells', 'type': 'DRUG', 'otherNames': ['APRIL CAR-T cells injection'], 'description': 'Each subject receive APRIL CAR T-cells by intravenous infusion', 'armGroupLabels': ['Administration of APRIL CAR T-cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}], 'facility': 'The First Affiliated Hospital，College of Medicine, 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'}}}}