Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06644118
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2024-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-09-28', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Within 28 days post CAR-T infusion', 'description': 'Adverse events will be assessed based on the CTCAE 5.0'}, {'measure': 'Treatment emergent adverse event (TEAE) incidence and severity', 'timeFrame': 'From aphresis till 1 year after CAR-T infusion or start of a new anti-cancer therapy, whichever is earlier', 'description': 'Adverse events will be assessed based on the CTCAE 5.0'}], 'secondaryOutcomes': [{'measure': 'Level of Immunogenicity', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'To assess the presence of antibodies to OL-101 (ADA)'}, {'measure': 'Level of RCL', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'To determine whether Replication Competent Lentivirus (RCL) is present in patient that receive OL-101'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'Proportion of subjects with PR or above'}, {'measure': 'Minimal residual disease (MRD) negative rate', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'Proportion of subjects with MRD negative status as defined by the IMWG response criteria'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The time from the initial response to therapy until the disease progression or relapse.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The time from CAR-T cell infusion to the first assessment of disease progression or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The time from CAR-T cell infusion to death from any cause.'}, {'measure': 'Cmax of OL-101', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The maximum concentration of the CAR-T cells will be measured to assess OL-101 in vivo expansion and persistence.'}, {'measure': 'Tmax of OL-101', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The time of the maximum concentration will be measured to assess OL-101 in vivo expansion and persistence.'}, {'measure': 'AUC 0-28days of OL-101', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'Area under the curve will be measured to assess OL-101 in vivo expansion and persistence.'}, {'measure': 'Serum cytokines', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'The levels of cytokines will be measured, such as IL-6 and ferritin.'}, {'measure': 'Serum soluble circulating BCMA (sBCMA)', 'timeFrame': 'Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first', 'description': 'Serum soluble circulating BCMA will be measured to explore its potential relationship to response or resistance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OL-101', 'Multiple myeloma', 'Phase 1', 'single arm'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).', 'detailedDescription': 'This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria\n* Relapsed/refractory multiple myeloma as defined by:\n\n 1\\) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).\n\n 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.\n* Measurable disease at screening as defined by any of the following:\n\n 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or\n 2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n* Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy\n* ECOG 0-1\n* Expected life expectancy exceeds 12 weeks\n* Adequate bone marrow reserve or organ function meeting the following criteria:\n\n 1. Hemoglobin ≥ 70 g/L\n 2. Platelet count ≥ 50 × 10\\^9/L\n 3. Absolute lymphocyte count ≥ 0.3×10\\^9/L\n 4. Absolute neutrophil count ≥ 1.0 × 10\\^9/L\n 5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN)\n 6. Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required)\n 7. Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).\n 8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L)\n 9. SpO2\\>92% on room air\n 10. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound\n\nExclusion Criteria:\n\n* Solitary plasmacytoma\n* Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.\n* Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening\n* Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast\n* Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk.\n* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis."}, 'identificationModule': {'nctId': 'NCT06644118', 'briefTitle': 'A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)', 'orgStudyIdInfo': {'id': 'OL-101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OL-101 infusion', 'description': 'This arm provides CAR-T treatment at the dose the patient is assigned to.', 'interventionNames': ['Biological: OL-101 infusion']}], 'interventions': [{'name': 'OL-101 infusion', 'type': 'BIOLOGICAL', 'description': 'OL-101 infusion will be administered to patients via IV infusion at the assigned dose.', 'armGroupLabels': ['OL-101 infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiequn Chen, MD, PHD', 'role': 'CONTACT', 'email': '20203009@nwu.edu.cn', 'phone': '(+86)13991832567'}, {'name': 'Xiequn Chen, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Beijing Gobroad Boren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '710016', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yajin Zhang, MD, PHD', 'role': 'CONTACT', 'email': 'zhangyj3@gobroadhealthcare.com', 'phone': '(+86)18601333856'}, {'name': 'Yajin Zhang, MD, PHD', 'role': 'CONTACT'}], 'facility': "The Affiliated Hospital of Northwest University Xi'an No.3 Hospital", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '3100003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD, 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, MD, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '(+86)13605714822'}, {'name': 'Yongxian Hu, MD, PhD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '(+86)15957162012'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Overland Therapeutics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}