Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT07107204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'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': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Dose limited toxicity(DLT)', 'timeFrame': 'Through the dose escalation phase, an average of 10 months'}, {'measure': 'Maximum tolerable dose(MTD)', 'timeFrame': 'Through the dose escalation phase, an average of 10 months'}, {'measure': 'Recommended phase 2 dose(RP2D)', 'timeFrame': 'Through the study completion, an average of 2.5 years'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) on tumor assessments', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Progression-free survival (PFS) on tumor assessments', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Duration of response (DoR) on tumor assessments', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Disease control rate (DCR) on tumor assessments', 'timeFrame': 'Through the study completion, an average of 2.5years'}, {'measure': 'Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level', 'timeFrame': 'Through the study completion, an average of 2.5 years'}, {'measure': 'ADA and NAb incidence', 'timeFrame': 'Through the study completion, an average of 2.5 years'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Hematologic Malignancies', 'Leukemia', 'Lymphoma', 'Multiple Myeloma (MM)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with relapsed or refractory hematologic malignancies, regardless of gender, aged between 18(inclusive) and 70 years .\n\nParticipants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.\n2. Age:≥18 and \\<70 years, any gender.\n3. Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .\n4. Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.\n5. Measurable Disease.\n6. Relapsed/Refractory Status.\n7. Adequate organ and hematologic function.\n8. An ECOG activity status score of 0-1.\n9. A life expectancy of ≥ 3 months.\n10. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL).\n2. Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.\n3. Patients with isolated extramedullary leukemia and multiple myeloma.\n4. Patients with uncontrolled active central nervous system leukemia (CNSL).\n5. Patients who have received anticancer therapy prior to administration.\n6. A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.\n7. A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities ,severe pulmonary disease that may lead to severe episodes of dyspnea,head trauma, impaired consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhagic disease.\n8. A severe acute or chronic infection when enrollment.\n9. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .\n10. Unresolved \\> grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.\n11. Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.\n12. A history of other type of malignancies.\n13. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.\n14. Poor compliance.\n15. A history of alcohol/drugs abuse.\n16. Current pregnancy or breastfeeding.\n17. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.'}, 'identificationModule': {'nctId': 'NCT07107204', 'briefTitle': 'A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotroy Therapeutics'}, 'officialTitle': 'A Multicenter, Open-label, Single-arm Phase Ib/IIa Clinical Study to Evaluate the Safety and Efficacy of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'BT02-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose escalation and expansion', 'interventionNames': ['Drug: BT02']}], 'interventions': [{'name': 'BT02', 'type': 'DRUG', 'description': 'BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks', 'armGroupLabels': ['dose escalation and expansion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical development director', 'role': 'CONTACT', 'email': 'clin.oper@biotroy.cn', 'phone': '+86-18602185973'}], 'overallOfficials': [{'name': 'Ying Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotroy Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}