Pulmovinci in Idiopathic Pulmonary Fibrosis: NCT05657184 Clinical Landscape Report 2026
Explore the PatSnap Life Sciences MCP marketplace
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: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Completed
Recruitment status
not reported
Planned enrollment
2023-06-09
Primary-completion proxy
Executive view
NCT05657184 evaluates Pulmovinci in Idiopathic Pulmonary Fibrosis. The disclosed sponsor is Regend Therapeutics Co. Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence and severity of the cell therapy-related adverse events (AEs), assessed over Within 24 weeks after treatment.
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 NCT05657184 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Idiopathic Pulmonary Fibrosis landscape. Drug & Asset MCP drug_fetch was queried for Pulmovinci, while Company & Deal Intelligence MCP organization_fetch was queried for Regend Therapeutics 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 |
|---|---|---|---|---|---|---|
| NCT05657184 | Pulmovinci | Phase 1 / Completed | Regend Therapeutics Co. Ltd. | China | Incidence and severity of the cell therapy-related adverse events (AEs) Within 24 weeks after treatment | 2023-06-09 |
| NCT06181370 | AGMB-447 | Phase 1 / Completed | AgomAb Therapeutics NV | United Kingdom | Number of participants with adverse events From Screening Through Study Completion, up to 8 Weeks | 2026-04-29 |
| NCT06160440 | Sufenidone | Phase 1 / Completed | Guangzhou Jiayue Pharmaceutical Technology Co., Ltd. | China | Incidence and severity of adverse events and serious adverse events related drug. Evaluations will be conducted for up to 7 days after first administra… | 2021-09-23 |
| NCT06135363 | Sufenidone | Phase 1 / Completed | Guangzhou Jiayue Pharmaceutical Technology Co., Ltd. | China | Incidence and severity of adverse events and serious adverse events related drug. From baseline to 7 days | 2023-01-14 |
| NCT06132256 | Axatilimab-csfr | Phase 2 / Active, not recruiting | Syndax Pharmaceuticals, Inc. | Canada, South Korea, Romania, Belgium, Czechia, Taiwan Province, Poland, United Kingdom, Italy, France, Australia, Germany, Spain | Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL]) Baseline through Week 26 | 2026-09-01 |
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.
Reproduce the trial-to-asset workflow with PatSnap MCP
Protocol design and endpoint interpretation
NCT05657184 is a Phase 1, completed study with not reported planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Incidence and severity of the cell therapy-related adverse events (AEs)” over “Within 24 weeks after treatment.” The retrieved endpoint description is: Dose escalation is based on incidence of cell therapy-related AEs. Severity of cell therapy-related adverse events (AEs) is evaluated according to Common Terminology Criteria for Adverse Events (CTCAE)..
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 not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. 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
0 recent result records were selected as contextual evidence for Idiopathic Pulmonary Fibrosis. These records do not establish direct evidence for NCT05657184 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
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
Pulmovinci is indexed as Cell therapy with target not reported biology and a global stage of Phase 3. The asset profile lists XLotus Therapeutics Co, Ltd. as an originator or developer.
Regend Therapeutics Co. Ltd. is indexed in an unreported country with the website http://www.regend.cn. Regend Therapeutics focuses on the human organ regenerative medicine business The record lists 10 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 Pulmovinci 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: NCT05657184
Protocol source: https://clinicaltrials.gov/study/NCT05657184
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: 15 October 2026.
Pulmovinci in Idiopathic Pulmonary Fibrosis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence and severity of the cell therapy-related adverse events (AEs) and 2023-06-09 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
