Trial reportBMJ (Clinical research ed.)2025
Anti-CD38 monoclonal antibody CM313 for primary immune thrombocytopenia: multicentre, randomised, placebo controlled, phase 2 trial.
Trial report in BMJ (Clinical research ed.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06199089 (A Randomized, Double-blind, Placebo-controlled, and Multi-center Clinical Study to Assess Safety and Efficacy of Anti-Human CD38 Monoclonal Antibody CM313 in the Treatment of Primary Immune Thrombocytopenia), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, and Multi-center Clinical Study to Assess Safety and Efficacy of Anti-Human CD38 Monoclonal Antibody CM313 in the Treatment of Primary Immune Thrombocytopenia
Who cites it
6 citing papers in PubMed.
- Single-Cell Transcriptomic Profiling Identifies B Cell-Intrinsic Dysregulation of Sphingolipid Biosynthesis and Could Be Improved by Inhibiting UGCG in Primary Immune Thrombocytopenia.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Reprogramming rather than depleting immunity: Targeting the CD38-NADClinical and translational medicine · 2026Article
- Targeting CD38 Across Autoimmune and Plasma Cell-Driven Immune-Mediated Diseases: Rationale, Clinical Evidence, and Emerging Therapeutic Landscape.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Artificial intelligence prediction of therapy response in newly diagnosed adult severe primary immune thrombocytopenia.Research and practice in thrombosis and haemostasis · 2026Article
- Daratumumab in patients with immune thrombocytopenia: a single-center, open-label, phase 2 trial.EClinicalMedicine · 2026Article
- Anti-CD38 monoclonal antibodies in multiple myeloma and beyond: immunotherapeutic mechanisms, evidence maturity, and clinical positioning.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the efficacy and safety of CM313, an anti-CD38 monoclonal antibody, in adults with persistent or chronic primary immune thrombocytopenia.
designMulticentre, randomised, placebo controlled, phase 2 trial.
settingFive hospitals in China, 16 January to 11 June 2024.
participants45 patients aged ≥18 years with persistent or chronic immune thrombocytopenia who failed to respond to, or relapsed after, glucocorticoid treatment but had previously responded to standard first line treatment.
interventionsPatients were randomised to receive intravenous CM313 (16 mg/kg) or placebo weekly for eight weeks.
main outcome measuresThe primary outcome was overall response rate (at least two consecutive platelet counts ≥30×10
resultsOf 56 patients screened, 45 were randomised to receive CM313 (n=30) or placebo (n=15). At week 8, the overall response rate was higher in the CM313 group (83%; 25/30) compared with placebo group (20%; 3/15): difference 63.3% (95% confidence interval 33.7% to 81.3%; P<0.001). The median time to a platelet count of ≥50×10
conclusionCM313 showed a favourable safety profile and encouraging efficacy in adults with persistent or chronic primary immune thrombocytopenia, characterised by rapid increase in platelet count, sustained platelet responses, and manageable adverse events.
trial registrationClinicalTrials.gov NCT06199089.
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