Adoptive Cell Therapy Across Cancer Diagnoses

Only patients within the Danish Healthcare system are eligible for enrollment.

Inclusion Criteria

• Histologically verified metastatic or locally advanced cancer diagnosis
• At least one lesion (>1 cm3) available for surgical resection
• Not candidate for standard treatment options
• Age of 18-70 years
• Performance status of 1 or 0.
• Life expectancy > 6 months
• One or more measurable parameter according to RECIST 1.1.
• No significant toxicity from previous cancer treatments (CTC≤1). Except alopecia (CTC≤2) or neuropathy (CTC≤2)
• Sufficient organ function, including:
• Absolute neutrophil count (ANC) ≥ 1.500 /µl
• Leucocyte count ≥ normal limit
• Platelets ≥ 100.000 /µl and 40 and INR<1,5
• Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
• Signed statement of consent after receiving oral and written study information
• Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.

Exclusion Criteria

• A history of prior malignancies. Patients treated for another malignancy can only participate if they are without signs of disease for a minimum of 3 years after last treatment.
• Primary brain tumor or verified brain metastases
• Known hypersensitivity to one of the active drugs or excipients.
• Significant medical conditions, including but not limited to severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus.
• Creatinine clearance below 70 ml/min .
• Acute or chronic infections with HIV, hepatitis, syphilis etc.
• Severe allergies or previous anaphylactic reactions.
• Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren's syndrome, sclerodermia, myasthenia gravis, goodpastures disease, addison's disease, hashimoto's thyroiditis, graves' disease etc.
• Pregnant women and women who are breastfeeding.
• Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone methotrexate etc.)
• Simultaneous treatment with other experimental drugs.
• Simultaneous treatment with other systemic anti-cancer treatments.
• Patients with active or uncontrollable hypercalcemia.