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NCT07339540
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
EARLY_PHASE1 trial testing V001-BCMA in Recurrent or Refractory Systemic Lupus Erythematosus in 45 participants. Currently enrolling.
30 October 2028
Quick facts
| Lead sponsor | Tongji Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 4 November 2025 |
| Primary completion | 30 October 2028 |
| Estimated completion | 30 October 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- V001-BCMA — full drug profile →
Conditions studied
- Recurrent or Refractory Systemic Lupus Erythematosus — all drugs for Recurrent or Refractory Systemic Lupus Erythematosus →
- Recurrent or Refractory IgG4 Related Diseases — all drugs for Recurrent or Refractory IgG4 Related Diseases →
- Recurrent or Refractory Systemic Sclerosis — all drugs for Recurrent or Refractory Systemic Sclerosis →
- Recurrent or Refractory Idiopathic Inflammatory Myopathy — all drugs for Recurrent or Refractory Idiopathic Inflammatory Myopathy →
Sponsor
Tongji Hospital
Who can join
Adults 18 to 65, any sex, with Recurrent or Refractory Systemic Lupus Erythematosus or Recurrent or Refractory IgG4 Related Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in autoimmune disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07339540
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07527260 — Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR · NA · not yet recruiting
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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 NCT07339540 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tongji Hospital
- Last refreshed: 14 January 2026
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/NCT07339540.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing