RD-0605 in Idiopathic Inflammatory Myopathies: NCT07674147 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: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Early Phase 1
Clinical phase
Not yet recruiting
Recruitment status
30
Planned enrollment
2029-07-01
Primary-completion proxy
Executive view
NCT07674147 evaluates RD-0605 in Idiopathic Inflammatory Myopathies. The disclosed sponsor is The Children's Hospital of Zhejiang University School of Medicine, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs), assessed over From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion).
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 NCT07674147 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Idiopathic Inflammatory Myopathies landscape. Drug & Asset MCP drug_fetch was queried for RD-0605, while Company & Deal Intelligence MCP organization_fetch was queried for The Children's Hospital of Zhejiang University School of Medicine.
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 |
|---|---|---|---|---|---|---|
| NCT07674147 | RD-0605 | Early Phase 1 / Not yet recruiting | The Children's Hospital of Zhejiang University School of Medicine | China | Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special In… From signing of informed consent through 90 days post-infusion (for r… | 2029-07-01 |
| ISRCTN76569516 | Belimumab | Phase 3 / Recruiting | University College London | United Kingdom, | 2029-08-31 | |
| NCT07751848 | Anifrolumab-FNIA | Phase 3 / Not yet recruiting | AstraZeneca PLC | China | The proportion of patients who achieve DORIS remission at week 52 Week 52 | 2028-08-25 |
| NCT07749430 | ACG102 | Early Phase 1 / Not yet recruiting | Wuhan Xiehe Hospital Tower | Geography not reported | Incidence of dose-limiting toxicities (DLTs) Within 21 days after first dose | 2027-01-30 |
| NCT07748156 | SNC116 | Early Phase 1 / Not yet recruiting | Nanjing Drum Tower Hospital | China | Safety Evaluation Within 3 months after SNC116 treatment. | 2030-01-01 |
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
NCT07674147 is a Early Phase 1, not yet recruiting study with 30 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)” over “From signing of informed consent through 90 days post-infusion (for related AEs, up to 24 months post-infusion).” The retrieved endpoint description is: Incidence of TEAEs, SAEs, and AESIs following RD06-05 infusion. AESIs include cytokine release syndrome (CRS) of grade ≥3, immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, graft-versus-host disease (GvHD) of any grade, infections of grade ≥3, secondary malignancies of any grade, and cardiac disorders of any grade..
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 30 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
5 recent result records were selected as contextual evidence for Idiopathic Inflammatory Myopathies. These records do not establish direct evidence for NCT07674147 unless the registration number matches.
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF 06823859 IN A…
Phase 2; n=8; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243 Source: https://clinicaltrials.gov/ct2/show/results/NCT05879718
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
Phase 2; n=149; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 10 Participants ; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 15 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT06161116
Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findin…
Phase 2; n=100; CLASI-A(16-week) = -44.0 % ( -55 to -33); CLASI-A(16-week) = -68.0 % ( -75 to -61) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42107375/
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
RD-0605 is indexed as Universal CAR-T with BCMA x CD19 biology and a global stage of Early Phase 1. The asset profile lists Nanjing Bioheng Biotech Co., Ltd. as an originator or developer.
No exact Company & Deal Intelligence profile was returned for The Children's Hospital of Zhejiang University School of Medicine. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 RD-0605 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: NCT07674147
Protocol source: https://clinicaltrials.gov/study/NCT07674147
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: 16 September 2026.
RD-0605 in Idiopathic Inflammatory Myopathies is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) and 2029-07-01 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
