Autoimmune Cytopenia, Autoimmune Hemolytic Anemia, Evans Syndrome, Immune Thrombocytopenia (ITP)
Conditions
Brief summary
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Interventions
BIOLOGICALCM336 Injection
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntary provision of written informed consent and ability to comply with protocol requirements. * Age ≥18 years, male or female. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. * Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome. * Relapsed or refractory autoimmune hemolytic anemia.
Exclusion criteria
* 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. * Other types of AIHA or other types of cytopenia * 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. * Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody. * Evaluated unsuitable to participant in this study by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 52 weeks | 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. |
| Efficacy of CM336 | 8 weeks | Overall hematological response rate within 8 weeks |
| Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit. | up to 52 weeks. | Proportion of ITP subjects with a platelet count ≥ 50 × 10\^9/L at least twice during the visit. |
| 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. | 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. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed