NCT07791615 Stapokibart Extranodal NK-T-Cell Lymphoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07791615 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: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07791615 is a hot trial to watch
Extranodal NK-T-Cell Lymphoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07791615 is notable because it evaluates Stapokibart in a Phase 2 design sponsored by Cancer Hospital Chinese Academy of Medical Sciences. 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 | NCT07791615 |
| Official title | A Phase II Study of Stapokibart Combined With Immune Checkpoint Inhibitors in Relapsed/Refractory Lymphoma |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Stapokibart |
| Sponsor | Cancer Hospital Chinese Academy of Medical Sciences |
| Geography | Not reported in the indexed record |
| Enrollment | 20 |
| Primary endpoint | Overall response rate (ORR) |
| Endpoint time frame | 6 months |
| Primary completion / readout proxy | Not reported |
Protocol design and endpoint interpretation
This is an open-label clinical study designed to evaluate the efficacy of Stapokibart combined with immune checkpoint inhibitors in patients with relapsed/refractory lymphoma. Approximately 20 patients with relapsed/refractory lymphoma who have failed prior immune checkpoint inhibitor therapy or failed to achieve remission are planned to be enrolled.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 20 participants across Not reported in the indexed record 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.
- Overall response rate (ORR) (6 months) — Overall response rate
- Treatment-Emergent Adverse Event (TEAE), Treatment-Related Adverse Event (TRAE) (through study completion, an average of 1.5 years) — safety
Readout outlook and evidence gap
The current protocol points to Not reported 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
Drug & Asset MCP profile: Stapokibart is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Cancer Hospital Chinese Academy of Medical Sciences is resolved to a normalized organization record in Beijing Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.
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
NCT07791615 provides a focused lens on Extranodal NK-T-Cell Lymphoma development. Its value will be determined by whether Stapokibart can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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