Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT06429150
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010954', 'term': 'Plasmacytoma'}], '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': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with treatment related adverse effects', 'timeFrame': '1 month', 'description': 'The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0'}], 'secondaryOutcomes': [{'measure': 'Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion', 'timeFrame': '1 year', 'description': 'Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood'}, {'measure': 'Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma', 'timeFrame': '1 year', 'description': 'Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'chimeric antigen receptor', 'BCMA', 'GPRC5D'], 'conditions': ['Multiple Myeloma', 'Plasmacytoma']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.', 'detailedDescription': 'Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.\n\nBCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.\n\nGPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.\n\nThis trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects with multiple myeloma or plasmacytoma\n* Strictly complete remission (sCR) is a treatment goal\n* Expected survival \\> 12 weeks\n* After prior auto-SCT is eligible regardless of other prior therapies\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given and commitment to continued follow-up\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Uncontrolled active infection\n* Active HIV, hepatitis B or hepatitis C infection\n* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n* Any medical conditions that may preclude participation'}, 'identificationModule': {'nctId': 'NCT06429150', 'briefTitle': 'Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Geno-Immune Medical Institute'}, 'officialTitle': 'Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy', 'orgStudyIdInfo': {'id': 'GIMI-IRB-24001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T cells to treat MM', 'interventionNames': ['Biological: CAR-T cells']}], 'interventions': [{'name': 'CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Infusion of multi-CAR-T cells', 'armGroupLabels': ['CAR-T cells to treat MM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lung-Ji Chang, ph.D', 'role': 'CONTACT', 'email': 'c@szgimi.com', 'phone': '86-0755-86725195'}, {'name': 'Vitaly Dubov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shenzhen Geno-immune Medical Institute', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '690105', 'city': 'Vladivostok', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vitaly Dubov, MD', 'role': 'CONTACT', 'email': 'drvdubov@gmail.com', 'phone': '8(924)3321996'}], 'facility': 'Hematologist of the Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}], 'centralContacts': [{'name': 'Lung-Ji Chang, ph.D', 'role': 'CONTACT', 'email': 'c@szgimi.org', 'phone': '86-0755 86725195'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Geno-Immune Medical Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The No.2 Clinical Hospital of the Ministry of Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}