Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 12:55 AM
Study NCT ID:
NCT06369935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720487', 'term': 'CT103A chimeric antigen receptor'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Response Rate， BOR', 'timeFrame': 'up to 24 weeks', 'description': 'Patients treatmented with Equecabtagene Autoleucel, the optimal disease state evaluated by the researcher is strict complete response (sCR),complete response (CR), very good partial response (Very Good Partial Response (VGPR) or partial response (partial response,PR) rate.'}], 'secondaryOutcomes': [{'measure': 'PFS rate of 6 month', 'timeFrame': 'up to 24 weeks', 'description': 'Probability of patients not experiencing disease progression or death from any cause 6 months after starting treatment with equecabtagene autoleucel'}, {'measure': 'OS rate of 6 month', 'timeFrame': 'up to 24 weeks', 'description': 'Probability of patient survival 6 months after equecabtagene autoleucel treatment'}, {'measure': 'Time to Response， TTR', 'timeFrame': 'up to 24 weeks', 'description': 'From the time the patient received equecabtagene autoleucel to the first recorded remission of the disease'}, {'measure': 'Time to Complete Response， TTCR', 'timeFrame': 'up to 24 weeks', 'description': 'From the time the patient received equecabtagene autoleucel to the first recorded complete remission of the disease (time interval between CR or sCR)'}, {'measure': 'Adverse Event， AE', 'timeFrame': 'up to 24 weeks', 'description': 'After the patient received treatment with equecabtagene autoleucel, the investigators considered all adverse events and serious adverse events (SAE) related to the treatment with Equecabtagene Autoleucel.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data', 'detailedDescription': 'Primary endpoint:\n\nBest Overall Response Rate (BOR): The proportion of patients who receive treatment with Ikeolensay injection and have been evaluated by researchers as having the best disease status is strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).\n\nSecondary endpoint:\n\nProgress Free Survival (PFS) rate at 6 months: The probability of patients not experiencing disease progression or death from any cause after receiving treatment with Ikeolensay injection for 6 months; Overall survival (OS) rate at 6 months: the probability of survival of patients after receiving treatment with Ikeolensay injection for 6 months; Time to Response (TTR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recorded time of disease remission; Time to Complete Response (TTCR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recording of complete disease response (CR or sCR); Adverse Event (AE): After receiving treatment with Ikeolensay Injection, researchers consider all adverse events and serious adverse events (SAE) related to Ikeolensay Injection treatment; Hospitalization: After receiving treatment with Ikeolensay injection, the researcher considers any hospitalization related to Ikeolensay injection treatment (including the reason, duration, and outcome of hospitalization); Death: The death of the patient after receiving treatment with Ikeolensay injection, recording the date and cause of death (any reason); Secondary malignant tumors: For any secondary malignant tumors discovered during the monitoring process, researchers can obtain tumor biopsy samples and other necessary samples of tumor tissue according to clinical needs, relevant guiding principles, and product instructions for safety analysis; Quality of life: Evaluate the quality of life using the EQ-5D and EORTCQLQ C30 scoring standards; Medical resource utilization: Collect any medical resource utilization information related to the treatment of patients with Ikeolensay injection (including hospitalization, emergency, outpatient, and new prescription drug usage).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population of this study was adult patients with relapsed/refractory multiple myeloma who were treated in real world with equecabtagene autoleucel, a commercially available product.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with confirmed relapsed/refractory multiple myeloma;\n* Based on clinical practice, the physician decided to administer equecabtagene autoleucel treatment;\n* Voluntarily sign the informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* Patients who are hypersensitive to the active ingredients of the product or any excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);\n* The researcher believes that patients are unable to return for follow-up visits or that it is impossible to complete the study;\n* Patients with expected survival less than 3 months'}, 'identificationModule': {'nctId': 'NCT06369935', 'briefTitle': 'A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.', 'orgStudyIdInfo': {'id': '20240407'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Equecabtagene Autoleucel', 'type': 'DRUG', 'otherNames': ['CT103A'], 'description': 'Equecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Yang Liu', 'role': 'CONTACT', 'email': 'pkuphliuyang@bjmu.edu.cn', 'phone': '+8613716926210'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Liu, Doctor', 'role': 'CONTACT', 'email': 'pkuphliuyang@bjmu.edu.cn', 'phone': '+8613716926210'}, {'name': 'Jin Lu', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jin Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jin Lu, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}