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

ConditionsImmune Thrombocytopenia (ITP)Treatment
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CM336 Injection

    Drug

    subcutaneous CM336 administration step-up dosing Dose and frequency of CM336 according to the protocol

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention(CM336)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the efficacy after CM336 treatment at week 12

Proportion of subjects whose platelet counts ≥ 30×10\^9/L and at least two times of baseline platelet count without bleeding at week 12

Time frame
12 weeks
2

Safety of CM336

Incidence, severity, and relationship of treatment emergent adverse events after CM336 treatment

Time frame
52 weeks

Secondary outcomes

1

Proportion of subjects with a platelet count ≥ 50 × 10^9/L and ≥ 100 × 10^9/L at each visit

Proportion of subjects with a platelet count ≥ 50 × 10\^9/L and ≥ 100 × 10\^9/L at each visit after administration.

Time frame
52 weeks
2

Duration from treatment initiation to platelet count ≥30×10^9/L and at least two times of baseline platelet count, platelet count ≥50×10^9/L, platelet count ≥100×10^9/L

Duration from treatment initiation to platelet count ≥30×10\^9/L and at least two times of baseline platelet count, platelet count ≥50×10\^9/L, platelet count ≥100×10\^9/L

Time frame
52 weeks
3

Cumulative weeks of platelet ≥30×10^9/L and at least two times of baseline platelet count, platelet count ≥50×10^9/L, platelet count ≥100×10^9/L

Cumulative weeks of platelet ≥30×10\^9/L and at least two times of baseline platelet count, platelet count ≥50×10\^9/L, platelet count ≥100×10\^9/L

Time frame
52 weeks
4

Other efficacy evaluation

Platelet counts at each visit

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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