IgA-based immunotherapy development and evaluation using the blood of healthy volunteers

IgA-based immunotherapy development and evaluation using the blood of healthy volunteers - INVOLVE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54864

Enrollment

Registered

2021-04-20

Start date

2022-03-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy individual, 18-55 years of age, bodyweight: above 50 kg. Being able and willing to complete the informed consent process.

Exclusion criteria

Exclusion criteria: Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C. A condition in which blood draw poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access. A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being. IgA deficiency, as well as rheumatoid arthritis and other chronic inflammatory conditions.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the percent change in the tumor cell viability after addition of IgA antibody and immune effector cells. In antibody-dependent, cell-mediated cytotoxicity assays (ADCC), the tumor cell viability is the endpoint measurement. In antibody-dependent, cell-mediated phagocytosis (ADCP) assays, the endpoint measurement is the number (percent) of cancer cells phagocytosed by macrophages as immune effector cells.	—

Measure

Time frame

The main study parameter is the percent change in the tumor cell viability after addition of IgA antibody and immune effector cells. In antibody-dependent, cell-mediated cytotoxicity assays (ADCC), the tumor cell viability is the endpoint measurement. In antibody-dependent, cell-mediated phagocytosis (ADCP) assays, the endpoint measurement is the number (percent) of cancer cells phagocytosed by macrophages as immune effector cells.

—

Secondary

Measure	Time frame
Secondary study parameters: percent change in tumor cell viability in ADCC/ADCP assays when innate checkpoint inhibition is combined with IgA treatment.	—

Countries

Netherlands

Outcome results