Adoptive Cell Therapy Across Cancer Diagnoses

• Status: Active, not recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inge Marie Svane
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine phosphate; Ipilimumab; Nivolumab

Criteria

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 aloplecia (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 <700.000 /µl

• Hemoglobin ≥ 6,0 mmol/l (regardless of prior transfusion)

• S-creatinine < 140

• S-bilirubin ≤ 1,5 times upper normal limit

• ASAT/ALAT ≤ 2,5 times upper normal limit

• Alkaline phosphatase ≤ 5 times upper normal limit

• Lactate dehydrogenase (LDH) ≤ 5 times upper normal limit

• Sufficient coagulation: PP-time>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.