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NCT06759948: KY2024-853
An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Phase 1 trial testing GC012F injection in Generalized Myasthenia Gravis (gMG) in 18 participants. Not yet recruiting.
13 February 2027
Quick facts
| Lead sponsor | Chongbo Zhao |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 15 February 2025 |
| Primary completion | 13 February 2027 |
| Estimated completion | 10 September 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- GC012F injection — full drug profile →
Conditions studied
- Generalized Myasthenia Gravis (gMG) — all drugs for Generalized Myasthenia Gravis (gMG) →
Sponsor
Chongbo Zhao
Who can join
Adults 18 to 75, any sex, with Generalized Myasthenia Gravis (gMG). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Research progress on chimeric antigen receptor-based immunotherapy against autoimmune diseases.
Jiang M, Zhao J, Yuan J, Yu Z, et al · · 2025 · cited 2× · PMID 40747591 · DOI 10.1080/21645515.2025.2538350 -
Roads and detours for CAR T cell therapy in autoimmune diseases.
Avouac J, Barzel A, Caiati D, Davis RS, et al · · 2026 · cited 1× · PMID 41588112 · DOI 10.1038/s41573-025-01349-4 -
Neurological implications of chimeric antigen receptor-T cell therapy.
Raffoul DG, Roos I, Mulazzani M, Anderson MA, et al · · 2026 · PMID 41877734 · DOI 10.1136/bmjno-2025-001491
Verify or expand the search:
- PubMed search for NCT06759948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GC012F injection
Trials testing the same drug.
- NCT07072884 — GC012F in Patients With Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07058298 — GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103) · EARLY_PHASE1 · recruiting
- NCT06419166 — An Exploratory Clinical Study of GC012F Injection for Refractory gMG · EARLY_PHASE1 · withdrawn
- NCT05846347 — Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus · Phase 1 · unknown
- NCT05858684 — Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients · EARLY_PHASE1 · unknown
Other recruiting trials for Generalized Myasthenia Gravis (gMG)
Currently open trials in the same condition.
- NCT07215949 — Zilucoplan for Severe gMG Exacerbations · Phase 3 · recruiting
- NCT07247279 — Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia · recruiting
- NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · recruiting
- NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With · Phase 2 · recruiting
- NCT07058298 — GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103) · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06759948 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chongbo Zhao
- Last refreshed: 6 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06759948.
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