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NCT03695757

Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG

Completed Phase 1, PHASE2 Last updated 6 July 2021
What this trial tests

Phase 1, PHASE2 trial testing Part A) Healthy subjects in Immunotherapy in 24 participants. Completed in 24 March 2021.

Timeline
6 November 2018
Primary endpoint
26 January 2021
24 March 2021

Quick facts

Lead sponsorAjou University School of Medicine
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment24
Start date6 November 2018
Primary completion26 January 2021
Estimated completion24 March 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Immunotherapy

Currently open trials in the same condition.

Other Ajou University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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