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Development of a GMP protocol for personalized adoptive T-cell therapy

Development of a GMP protocol for personalized adoptive T-cell therapy - Personalized adoptive T-cell therapy protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47022
Enrollment
40
Registered
2018-05-24
Start date
2016-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Immuuntherapie ontwikkeling bladder cancer head & neck cancer Lung cancer melanoma ovarian cancer

Interventions

Immunotherapy
neoantigens
therapy protocol development

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: a. Age >=18 years b. Written informed consent c. Histologically proven NSCLC, bladder, ovarian, melanoma, or head & neck cancer d. Performance score WHO 0 or 1 at time of study entry e. An indication for a routine diagnostic investigation or for therapeutic or palliative surgery during which a tumor biopsy can be taken or the presence of metastatic lesion(s) of which a biopsy can safely be obtained I. Patients with safely accessible metastases according to an interventional-radiologist* II. Patients not known to have bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries* f. Expected biopsy size of at least 5 core biopsies or 100 mm3 ;*These criteria are only applicable if the patient will have a biopsy solely for the purpose of this study.

Exclusion criteria

Exclusion criteria: a. Anemia (Hb 10 mg) or any other form of immunosuppressive drugs

Design outcomes

Primary

MeasureTime frame
The main study parameter/endpoint per patient will be the number and frequency of T-cell responses that can be generated against tumor neoantigens predicted from the autologous tumor mutanome of the patient.

Secondary

MeasureTime frame
The secondary study parameter/endpoint will be the frequency, phenotype, and functionality of the induced T-cells as characterized by functional assays and flow cytometry.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)