Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
Study NCT ID:
NCT04156269
Status:
UNKNOWN
Last Update Posted:
2019-11-12
First Post:
2019-11-06
Has Adverse Events:
False
Brief Title:
BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/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': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0', 'timeFrame': '28 days'}, {'measure': 'Type of dose-limiting toxicity (DLT)', 'timeFrame': '28 days'}, {'measure': 'Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '1 year', 'description': 'Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCMA', 'CS1', 'BCMA-CS1 cCAR T cells', 'CD269', 'SLAMF7'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.', 'detailedDescription': 'BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7).\n\nThe use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis based on the World Health Organization (WHO) 2008\n2. Patients have exhausted standard therapeutic options\n3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks\n4. Female must be not pregnant during the study\n\nExclusion Criteria:\n\n1. Prior solid organ transplantation\n2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant\n3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents'}, 'identificationModule': {'nctId': 'NCT04156269', 'briefTitle': 'BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'iCell Gene Therapeutics'}, 'officialTitle': 'Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'ICG182-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCMA-CD33 cCAR T cells', 'description': 'BCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs', 'interventionNames': ['Biological: BCMA-CS1 cCAR T cells']}], 'interventions': [{'name': 'BCMA-CS1 cCAR T cells', 'type': 'BIOLOGICAL', 'description': 'BCMA-CS1 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.', 'armGroupLabels': ['BCMA-CD33 cCAR T cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Liu, MD, PhD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'lfyh2006@yahoo.com'}], 'facility': 'Chengdu Military General Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyu Zhang, MD, PhD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'HongyuZhang@pkuszh.com'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Kevin Pinz', 'role': 'CONTACT', 'email': 'kevin.pinz@icellgene.com', 'phone': '6315386218'}], 'overallOfficials': [{'name': 'Hongyu Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Shenzhen Hospital'}, {'name': 'Fang Liu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu Military General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iCell Gene Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'Chengdu Military General Hospital', 'class': 'OTHER'}, {'name': 'iCAR Bio Therapeutics Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}