NCT03305341Active, not recruitingEarly phase 1
Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers. 1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains. 2. Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen. 3. The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 4 Oct 2017
- Start date
- 18 May 2025
- Primary completion date
- 18 Nov 2026
- Lead sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- NCT number
- NCT03305341
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 18 May 2025 to the primary completion date, 18 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\. Uncontrolled Cancers
- 2\. Severe or Critical Illness Severity
- 5\. The patients with other serious inter-current illness
- 6\. Serious Allergy
Other
- 3\. Pregnancy
- 4\. Breast-feeding
- 7\. Serious Bleed Tendency
- 8\. The prohibition of the biological product
Who the study is looking for
- Controlled Cancers
- Moderate COVID-19
- Positive testing by standard RT-PCR assay or equivalent testing
- Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute
- No clinical signs indicative of Severe or Critical Illness Severity
Criteria the registry did not label
- Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
- 20 Moderate COVID-19 patients with controlled cancers
Age in the registry: 24 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicine Invention Design Incorporation (MIDI) - IORG0007849 Coordinator of this site? Confirm its status | North Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.