Enhancing anti-melanoma activity of T-cells

Enhancing anti-melanoma activity of T-cells - MIO, Melanoma Immunotherapy Optimization

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36999

Enrollment

100

Registered

2012-12-04

Start date

2013-04-04

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

melanoma T-cell transfer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with primary and/or metastasized melanoma who need to undergo a surgical procedure

Exclusion criteria

Exclusion criteria: no exclusion criteria;

Design outcomes

Primary

Measure	Time frame
The main study parameter in vitro is the percentage enhancement of the anti-melanoma activity of autologous T-cells armed with scFv:TRAIL. Enhanced anti-tumour activity of T-cells will be assessed in vitro by evaluating their capacity to induce apoptosis and loss of cell viability in autologous melanoma cells. The main study parameter in vivo is the % increase in treatment efficacy determined in a mouse model xenografted with primary patient-derived melanoma cells and reconstituted with autologous patient-derived immune cells. Treatment efficacy will be assessed based on tumour outgrowth.	—

Measure

Time frame

The main study parameter in vitro is the percentage enhancement of the anti-melanoma activity of autologous T-cells armed with scFv:TRAIL. Enhanced anti-tumour activity of T-cells will be assessed in vitro by evaluating their capacity to induce apoptosis and loss of cell viability in autologous melanoma cells. The main study parameter in vivo is the % increase in treatment efficacy determined in a mouse model xenografted with primary patient-derived melanoma cells and reconstituted with autologous patient-derived immune cells. Treatment efficacy will be assessed based on tumour outgrowth.

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Secondary

Measure	Time frame
Additional in vitro parameters; T-cell proliferation (e.g. by CFSE fluorescent cell labelling), T-cell co-stimulation (e.g. by measurement of cytokine production), T-cell phenotype (e.g. by evaluation of TIM-3/PD-1 as markers for exhausted T-cells). Additional in vivo parameters: the number of tumor-infiltrated lymphocytes, the phenotype of infiltrated lymphocytes (incl. exhausted T-cell phenotype).	—

Measure

Time frame

Additional in vitro parameters; T-cell proliferation (e.g. by CFSE fluorescent cell labelling), T-cell co-stimulation (e.g. by measurement of cytokine production), T-cell phenotype (e.g. by evaluation of TIM-3/PD-1 as markers for exhausted T-cells). Additional in vivo parameters: the number of tumor-infiltrated lymphocytes, the phenotype of infiltrated lymphocytes (incl. exhausted T-cell phenotype).

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Countries

Netherlands

Outcome results