Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06799611

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-03-13

20

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of CM336 in the treatment of refractory adult primary immune thrombocytopenia

CONDITIONS

Official Title

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and above, male or female
  • Diagnosis of persistent or chronic immune thrombocytopenia (ITP)
  • Previous failure of glucocorticoid therapy
  • In second-line treatment phase, must meet one of the following: no response to at least one thrombopoietin receptor agonist; failure to maintain response after anti-CD20 or anti-CD38 monoclonal antibody therapy; no response or relapse after splenectomy
  • Platelet count less than 30 x 10^9/L within 48 hours before first dose
  • ECOG physical status score of 2 or less
  • Stable dose of maintenance treatment (including corticosteroids ≤20 mg prednisone, TPO receptor agonists) for at least 4 weeks before first dose
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-BCMA antibody drugs
  • Autoimmune hemolytic anemia or secondary/hereditary thrombocytopenia
  • History of thrombotic or embolic events within 12 months before first dose or extensive/severe bleeding
  • Participation in other clinical trials or exposure to other study drugs within 4 weeks or 5 half-lives before first dose
  • Use of anticoagulants or antiplatelet drugs within 3 weeks before first dose
  • ITP treatment (methylprednisolone, platelet, gamma-globulin infusion, or TPO receptor agonist) within 2 weeks before first dose
  • Splenectomy within 6 months before first dose
  • Use of azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus within 4 weeks before first dose; or CD20/CD38 monoclonal antibodies, cyclophosphamide, vindesine within 3 months before first dose
  • Received live vaccine within 4 weeks before first dose or planned during trial
  • History of allogeneic stem cell or organ transplantation
  • Serious diseases limiting participation (e.g., diabetes, liver/kidney insufficiency, severe cardiac conditions, gastric ulcer)
  • Malignant tumors within 5 years before screening
  • History of severe recurrent or chronic infection
  • Known or suspected immunosuppression
  • Significant laboratory abnormalities at screening
  • HIV or syphilis antibody positive
  • Active uncontrollable infection including hepatitis B or C
  • Pregnant or lactating women
  • Mental disorders preventing informed consent or trial participation
  • Unresolved toxicity symptoms from prior treatment
  • Other investigator-assessed ineligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yunfei Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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