An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
To evaluate the efficacy and safety of CM336 in the treatment of refractory adult primary immune thrombocytopenia
Eligibility criteria
Qualifiers
Age 18 and above, male or female;
Conform to the diagnostic criteria of persistent or chronic immune thrombocytopenia (ITP);
Failure of previous glucocorticoid therapy;
In the second-line treatment phase, eligible subjects must meet any of the following criteria: (1) Demonstrate no response to treatment with at least one thrombopoietin receptor agonist (including but not limited to recombinant human thrombopoietin [rhTPO], eltrombopag, hetrombopag, avatrombopag, or romiplostim); Fail to achieve sustained response (manifested as non-response, loss of response, or disease relapse) following anti-CD20 monoclonal antibody therapy (e.g., rituximab) or anti-CD38 monoclonal antibody therapy; (2) Exhibit no therapeutic response or experience disease relapse after splenectomy.
Disqualifiers
Received any treatment of anti-BCMA antibody drug;
Accompanied by autoimmune hemolytic anemia, or various secondary and hereditary thrombocytopenia;
History of any thrombotic or embolic events in the 12 months prior to the first dose or accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc;
Participated in any other study drug or exposure to other study drugs within 4 weeks or 5 half-lives before the first dose (whichever is longer);
Trial design
Treatments tested in this trial
- CM336 Injection
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov