Preparation of AKT-DC from Lymph nodes derived through Surgery and Endobronchial ultrasound guided biopsy in non-small cell lung cancer patients.

Preparation of AKT-DC from Lymph nodes derived through Surgery and Endobronchial ultrasound guided biopsy in non-small cell lung cancer patients. - PALSE-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51383

Enrollment

Registered

2022-07-18

Start date

2022-06-15

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

lung cancer Non-small cell lung cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >=18 years. • Able to understand the written information and able to give informed consent according to International Conference of Harmonisation (ICH)/ Good Clinical Practice (GCP). • Histologically or radiologically-proven diagnosis of NSCLC.

Exclusion criteria

Exclusion criteria: - Unable to receive extra-additional passes during EBUS and/or to undergo lymphocyte apheresis. - Pregnant or lactating - Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection.

Design outcomes

Primary

Measure	Time frame
1. To assess the feasibility of transposing Bioaccell AKT-DC manufacturing protocol as used by Kimura et al. to the Erasmus MC (EMC). 2. To optimize the generation of AKT-DCs from cytological specimens (EBUS-FNAs of hilar and mediastinal lymph nodes). 3. Validate production in a relevant study population. 4. Provide necessary documentation to submit a phase 1 clinical trial for approval [investigational medicinal product dossier (IMPD), investigator brochure, etc] in the most relevant and feasible clinical setting. 5. To gain a deeper understanding of the mode of action and therapeutic potential of AKT-DCs by performing a comprehensive analysis of cellular subsets and immunoreactivity within tumor-draining lymph nodes of NSCLC patients.	—

Measure

Time frame

1. To assess the feasibility of transposing Bioaccell AKT-DC manufacturing protocol as used by Kimura et al. to the Erasmus MC (EMC). 2. To optimize the generation of AKT-DCs from cytological specimens (EBUS-FNAs of hilar and mediastinal lymph nodes). 3. Validate production in a relevant study population. 4. Provide necessary documentation to submit a phase 1 clinical trial for approval [investigational medicinal product dossier (IMPD), investigator brochure, etc] in the most relevant and feasible clinical setting. 5. To gain a deeper understanding of the mode of action and therapeutic potential of AKT-DCs by performing a comprehensive analysis of cellular subsets and immunoreactivity within tumor-draining lymph nodes of NSCLC patients.

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Countries

Netherlands

Outcome results