Clinical Trials in China / NCT07175493
Recruiting
Phase 1/2
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
NCT07175493 · tracked via the Priya Life Science China tracker
Condition(s) studied
Autoimmune CytopeniaImmune Thrombocytopenia (ITP)Autoimmune Hemolytic AnemiaEvans Syndrome
Investigational drug(s) / intervention(s)
CM336 Injection: subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
Study summary
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | Recruiting |
| Blood Disease Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Recruiting |
More Keymed Biosciences Co.Ltd trials in China
Study of CM583 in Healthy Participants
Starting soon
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07175493 on ClinicalTrials.gov ↗ ← All trials in China