GC-012F in Myasthenia Gravis: NCT06759948 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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Not yet recruiting
Recruitment status
18
Planned enrollment
2027-02-13
Primary-completion proxy
Executive view
NCT06759948 evaluates GC-012F in Myasthenia Gravis. The disclosed sponsor is Shanghai Huashan Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Primary endpoints, assessed over Since signing the ICF until 24-week post-infusion or premature withdrawal from the study, whichever comes first..
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 NCT06759948 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Myasthenia Gravis landscape. Drug & Asset MCP drug_fetch was queried for GC-012F, while Company & Deal Intelligence MCP organization_fetch was queried for Shanghai Huashan Hospital.
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 |
|---|---|---|---|---|---|---|
| NCT06759948 | GC-012F | Phase 1 / Not yet recruiting | Shanghai Huashan Hospital | China | Primary endpoints Since signing the ICF until 24-week post-infusion or premature withdr… | 2027-02-13 |
| NCT07058298 | GC-012F | Early Phase 1 / Recruiting | Sponsor not reported | China | The frequency and severity of adverse events. Since signing the ICF until 24-week post-infusion or withdrawal from… | 2027-02-13 |
| NCT07039916 | Imeroprubart | Phase 3 / Recruiting | Immunovant Sciences Ltd. | Argentina, Romania, Hungary, Czechia, United States, United Kingdom, Spain, Greece, Poland, Denmark, Mexico, Italy, Serbia, Germany | Change from Baseline in MG-ADL Score for Antibody-positive Participants Baseline to Week 12 | 2027-12-01 |
| NCT07022197 | Anti-BAFFR CART(Tianjin Medical University General Hospital) | Phase 1/2 / Recruiting | Tianjin Medical University General Hospital | China | Types and incidence of dose-limiting toxicity (DLT) after BAFF-R CART cells infusion Up to 3 months post BAFF-R CART cells infusion | 2027-12-30 |
| NCT06987539 | Inebilizumab-cdon | Phase 2 / Recruiting | Amgen, Inc. | Argentina, United States, Poland, Brazil, France, Spain | Maximum Observed Concentration (Cmax) of Inebilizumab Up to Week 52 | 2030-03-13 |
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
NCT06759948 is a Phase 1, not yet recruiting study with 18 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Primary endpoints” over “Since signing the ICF until 24-week post-infusion or premature withdrawal from the study, whichever comes first..” The retrieved endpoint description is: 1、DLT incidence; DLT is defined as any of the following conditions associated with GC012F Injection occurring within 28 days post cell infusion: 1. Neurotoxicity: Grade 3 and 4, which cannot recover to Grade 2 or lower within 7 days after therapeutic intervention; 2. CRS: Grade 4, which cannot recover to Grade 2 or lower within 3 days after therapeutic intervention; 3. Non-hematological toxicity: Grade 3 and Grade 4, involving heart, lung and kidney, which cannot recover to Grade 2 or lower within 28 days after therapeutic intervention; Grade 5; 4. Hematological toxicity: Grade 4, which cannot recover to Grade 2….
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 18 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 Myasthenia Gravis. These records do not establish direct evidence for NCT06759948 unless the registration number matches.
A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholi…
Phase 3; n=119; MG-ADL Total Score Change From Baseline(Least Squares Mean) = -1.90 points on a scale (90% Confidence Interval, -2.51 to -1.28); MG-ADL Total Score Change From Baseline(Least Squares Mean) = -3.35 points on a scale (90% Confidence Interval, -3.98 to -2.72) Source: https://clinicaltrials.gov/ct2/show/results/NCT06298552
Management of Exacerbations and Rescue Therapy in the Phase 3 Myasthenia Gravis Inebilizumab Trial
Phase 3; n=238; exacerbation(26-week): HR = 0.41(95.0% CI, 0.24 - 0.7); exacerbation(26-week): HR = 0.41(95.0% CI, 0.24 - 0.7) Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42573995/
Assessment of sustained health- related quality of life in Phase 3 Vivacity-MG3 Trial of Nipocalimab versus Placebo in Generalized Myasthenia Gravis
Phase 3; n=129; EQ-5D-VAS(24-week) = 37.1 % ; EQ-5D-VAS(24-week) = 55.2 % Source: https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/journal/14681331
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
GC-012F is indexed as Autologous CAR-T with BCMA x CD19 biology and a global stage of Phase 3. The asset profile lists Gracell Biotechnologies (Shanghai) Co., Ltd. as an originator or developer.
Shanghai Huashan Hospital is indexed in China with the website http://www.huashan.org.cn. The organization record is used to resolve sponsor identity. 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 GC-012F 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: NCT06759948
Protocol source: https://clinicaltrials.gov/study/NCT06759948
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: 18 September 2026.
GC-012F in Myasthenia Gravis is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Primary endpoints and 2027-02-13 the leading decision points.
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