Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM336 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM336 Injection | Biological | subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 52 weeks |
| Efficacy of CM336 | Overall hematological response rate within 8 weeks | 8 weeks |
| Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit. | Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit. | up to 52 weeks. |
| 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. | 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. | up to 52 weeks. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 86+028-88610620 | qianjia@keymedbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D000744 | Anemia, Hemolytic, Autoimmune |
| C536380 | Evans Syndrome |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Heping Hospital Affiliated to Changzhi Medical College | Recruiting | Changzhi | Shanxi | China |
|
| Blood Disease Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |