CRT-402 in Myositis: NCT07778446 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: 11 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1/2
Clinical phase
Not yet recruiting
Recruitment status
34
Planned enrollment
2028-12-01
Primary-completion proxy
Executive view
NCT07778446 evaluates CRT-402 in Myositis. The disclosed sponsor is CREATE Medicines, Inc. (Massachusetts), the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs)., assessed over Up to 52 weeks.
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 NCT07778446 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Myositis landscape. Drug & Asset MCP drug_fetch was queried for CRT-402, while Company & Deal Intelligence MCP organization_fetch was queried for CREATE Medicines, Inc. (Massachusetts).
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 |
|---|---|---|---|---|---|---|
| NCT07778446 | CRT-402 | Phase 1/2 / Not yet recruiting | CREATE Medicines, Inc. (Massachusetts) | Australia | Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose… Up to 52 weeks | 2028-12-01 |
| NCT07760155 | ESG-206 | Phase 2 / Not yet recruiting | Shanghai Escugen Biotechnology Co., Ltd. | China | SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo Up to approximately 25 weeks | 2028-03-31 |
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
NCT07778446 is a Phase 1/2, not yet recruiting study with 34 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 treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs).” over “Up to 52 weeks.” The retrieved endpoint description is: Adverse events (AEs) are any new or worsening medical problems that occur after starting the study treatment..
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 34 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 Myositis. These records do not establish direct evidence for NCT07778446 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/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
CRT-402 is indexed as mRNA CAR-T with CD19 biology and a global stage of Phase 1/2. The asset profile lists CREATE Medicines, Inc. (Massachusetts) as an originator or developer.
CREATE Medicines, Inc. (Massachusetts) is indexed in United States with the website https://createmedicines.com. CREATE Medicines is a biotech company developing in vivo CAR therapies using mRNA-LNP immune cell programming technology. The record lists 11 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 CRT-402 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: NCT07778446
Protocol source: https://clinicaltrials.gov/study/NCT07778446
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: 11 September 2026.
CRT-402 in Myositis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), and dose-limiting toxicities (DLTs). and 2028-12-01 the leading decision points.
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