Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT07175493
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}, {'id': 'C536380', 'term': 'Evans Syndrome'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '52 weeks', 'description': 'Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and American Society for Transplantation and Cellular Therapy(ASTCT) criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.'}, {'measure': 'Efficacy of CM336', 'timeFrame': '8 weeks', 'description': 'Overall hematological response rate within 8 weeks'}, {'measure': 'Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.', 'timeFrame': 'up to 52 weeks.', 'description': 'Proportion of ITP subjects with a platelet count ≥ 50 × 10\\^9/L at least twice during the visit.'}, {'measure': 'Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.', 'timeFrame': 'up to 52 weeks.', 'description': 'Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Cytopenia', 'Immune Thrombocytopenia (ITP)', 'Autoimmune Hemolytic Anemia', 'Evans Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary provision of written informed consent and ability to comply with protocol requirements.\n* Age ≥18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.\n* Relapsed or refractory autoimmune hemolytic anemia.\n\nExclusion Criteria:\n\n* Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.\n* Other types of AIHA or other types of cytopenia\n* History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.\n* Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.\n* Evaluated unsuitable to participant in this study by investigator.'}, 'identificationModule': {'nctId': 'NCT07175493', 'briefTitle': 'A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keymed Biosciences Co.Ltd'}, 'officialTitle': 'A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia', 'orgStudyIdInfo': {'id': 'CM336-125101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CM336 injection', 'interventionNames': ['Biological: CM336 Injection']}], 'interventions': [{'name': 'CM336 Injection', 'type': 'BIOLOGICAL', 'description': 'subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol', 'armGroupLabels': ['CM336 injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu Zhou Henan Cancer Hospital', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '028-88610620'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Changzhi', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuliang Shen Heping Hospital Affiliated to Changzhi Medical College', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '028-88610620'}], 'facility': 'Heping Hospital Affiliated to Changzhi Medical College', 'geoPoint': {'lat': 36.18389, 'lon': 113.10528}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Zhang', 'role': 'CONTACT', 'email': 'zhanglei1@ihcams.ac.cn', 'phone': '86+022-23608025'}, {'name': 'Jun Shi', 'role': 'CONTACT', 'email': 'shijun@ihcams.ac.cn', 'phone': '86+022-23608025'}], 'facility': 'Blood Disease Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'qianjia@keymedbio.com', 'phone': '86+028-88610620'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keymed Biosciences Co.Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}