NCT07710248 Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen) Purpura, Thrombocytopenic, Idiopathic Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07710248 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07710248 is a hot trial to watch
Purpura, Thrombocytopenic, Idiopathic is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07710248 is notable because it evaluates Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen) in a Phase 2 design sponsored by Hangzhou Shangjian Biotechnology Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07710248 |
| Official title | SG301-SC Injection Safety Study in Subjects With Primary ITP Patients |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen) |
| Sponsor | Hangzhou Shangjian Biotechnology Co., Ltd. |
| Geography | China |
| Enrollment | 60 |
| Primary endpoint | Incidence of Treatment-Emergent Adverse Events |
| Endpoint time frame | up to 24 weeks |
| Primary completion / readout proxy | 2027-05-17 |
Protocol design and endpoint interpretation
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary objectives are to assess the pharmacokinetic, pharmacodynamic and immunogenicity profiles of SG301 SC Injection in ITP participants. A total of 60 ITP participants are planned to be enrolled in this study and randomly assigned at a 1:1:1 ratio to the low dose group, high dose group and placebo group, with approximately 20 participants per group. All participants enrolled in this study may receive concomitant background therapies at stable doses for at least 4 weeks prior to the first study drug administration, and is expected to be maintained throughout the study period.
Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of 60 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Incidence of Treatment-Emergent Adverse Events (up to 24 weeks) — Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6
- ORR (at Week 8 of treatment) — Overall platelet response rate
Readout outlook and evidence gap
The current protocol points to 2027-05-17 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Trial-sourced asset: Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen). The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Hangzhou Shangjian Biotechnology Co., Ltd.. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07710248 provides a focused lens on Purpura, Thrombocytopenic, Idiopathic development. Its value will be determined by whether Recombinant human anti-CD38 momoclonal antibody(Hangzhou Sumgen) can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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