Rocbrutinib in Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type: NCT07189065 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Recruiting
Recruitment status
150
Planned enrollment
2027-12-31
Primary-completion proxy
Executive view
NCT07189065 evaluates Rocbrutinib in Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type. The disclosed sponsor is Guangzhou Lupeng Pharmaceutical Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Overall Response Rate, assessed over Up to 24 Months.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07189065 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type landscape. Drug & Asset MCP drug_fetch was queried for Rocbrutinib, while Company & Deal Intelligence MCP organization_fetch was queried for Guangzhou Lupeng Pharmaceutical Co., Ltd..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07189065 | Rocbrutinib | Phase 2 / Recruiting | Guangzhou Lupeng Pharmaceutical Co., Ltd. | China | Overall Response Rate Up to 24 Months | 2027-12-31 |
| NCT07220187 | Cyclophosphamide | Phase 3 / Not yet recruiting | SWOG | Geography not reported | Progression free survival (PFS) Up to 7 years | 2035-10-01 |
| NCT07215585 | Surovatamig | Phase 3 / Recruiting | AstraZeneca PLC | Canada, South Korea, Hong Kong, Belgium, Japan, China, Turkey, Poland, Brazil, United Kingdom, Australia | SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse e… Up to 1 year | 2030-06-10 |
| NCT07200479 | CT1194D CAR-T Cells(Hematology Hospital of Chinese Academy of Medical Sciences) | Phase 1 / Not yet recruiting | Hematology Hospital of Chinese Academy of Medical Sciences | China | To assess the severity and incidence of DLTs, treatment-related adverse events (TRAE), and adverse events of special in… 12 months after CT1194D infusion | 2027-06-28 |
| NCT07197307 | Loncastuximab tesirine | Phase 2 / Recruiting | Universität Leipzig | Germany | Best overall response rate (BORR) 12 months after the start of study therapy | 2030-04-30 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07189065 is a Phase 2, recruiting study with 150 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Overall Response Rate” over “Up to 24 Months.” The retrieved endpoint description is: To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC)..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 150 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Lenalidomide, Bendamustine Hydrochloride, Rituximab as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type. These records do not establish direct evidence for NCT07189065 unless the registration number matches.
A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circu…
Phase 2; n=46; End of Treatment Complete Response (EOT CR) Rate = 73.3 Percentage of participants (95% Confidence Interval, 58.06 - 85.40) Source: https://clinicaltrials.gov/ct2/show/results/NCT04980222
A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 a Long-acting Human IL-7, Post-Kymriah®, Post-Yescarta®, or Post-Breyanzi® in Sub…
Phase 1; n=17; Any TEAEs = 3 Participants ; Any TEAEs = 2 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05075603
Ultralow-Dose Interleukin 10–Expressing Chimeric Antigen Receptor T Cells in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Phase 1; n=13; CR = 84.6 % Source: https://pubmed.ncbi.nlm.nih.gov/42490071/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Rocbrutinib is indexed as Small molecule drug with BTK biology and a global stage of Approved. The asset profile lists Guangzhou Lupeng Pharmaceutical Co., Ltd. as an originator or developer.
Guangzhou Lupeng Pharmaceutical Co., Ltd. is indexed in China with the website http://www.lupengbio.com. Lupeng Pharmaceutical is a biotech company that focuses on the drug discovery and development of novel therapies for cancer treatment. The record lists 7 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Rocbrutinib is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07189065
Protocol source: https://clinicaltrials.gov/study/NCT07189065
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
Rocbrutinib in Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Overall Response Rate and 2027-12-31 the leading decision points.
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