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NCT03695757
Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG
Phase 1, PHASE2 trial testing Part A) Healthy subjects in Immunotherapy in 24 participants. Completed in 24 March 2021.
26 January 2021
Quick facts
| Lead sponsor | Ajou University School of Medicine |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 6 November 2018 |
| Primary completion | 26 January 2021 |
| Estimated completion | 24 March 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Part A) Healthy subjects — full drug profile →
- Part B) Advanced solid tumor — full drug profile →
Conditions studied
- Immunotherapy — all drugs for Immunotherapy →
Sponsor
Ajou University School of Medicine
Who can join
19 and older, any sex, with Immunotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this prospective pilot clinical study is to evaluate the safety and immunostimulatory effect of intramuscularly administrations of autologous total IgG (autologous total IgG therapy) in healthy subjects and patients with advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, biliary cancer, melanoma, renal cell carcinoma etc.). In addition, antitumor effect of intramuscularly administrations of autologous total IgG in patients with advanced solid tumor will be also evaluated.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
B-Cell-Based Immunotherapy: A Promising New Alternative.
Gupta SL, Khan N, Basu S, Soni V. · · 2022 · cited 29× · PMID 35746487 · DOI 10.3390/vaccines10060879 -
Intramuscular administration of autologous total immunoglobulin G induces immunomodulatory effects on T cells in healthy human subjects: An open-labeled prospective single-arm trial.
Kwon B, Yang SJ, Cho SM, Kim ME, et al · · 2022 · cited 6× · PMID 35665739 · DOI 10.1097/md.0000000000029486
Verify or expand the search:
- PubMed search for NCT03695757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Ajou University School of Medicine trials
Trials by the same sponsor.
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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 NCT03695757 (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 Ajou University School of Medicine
- Last refreshed: 6 July 2021
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/NCT03695757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing