Status:
COMPLETED
Adoptive Cell Therapy Across Cancer Diagnoses
Lead Sponsor:
Inge Marie Svane
Conditions:
Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Adoptive cell therapy (ACT) is a personalized form of immunotherapy, where lymphocytes isolated from the patient's own tumor tissue are expanded 1000-fold ex-vivo and then infused back into the patien...
Eligibility Criteria
Inclusion
- Only patients within the Danish Healthcare system are eligible for enrollment.
- 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 \<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
- 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.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03296137
Start Date
October 13 2017
End Date
July 1 2020
Last Update
October 26 2024
Active Locations (1)
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1
Center for Cancer immune Therapy (CCIT), Dept. of Hematology and dept. of Oncology
Copenhagen, Denmark, 2730