Clinical trial · Interventional
Adoptive Cell Therapy Across Cancer Diagnoses
NCT03296137CI-TRIAL-00081937completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous tumor-infiltrating lymphocytes | Biological | Lifileucel | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludara | Drug | Fludarabine | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| proleukin | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor-infiltrating Lymphocyte (TIL) Therapy with checkpoint inhibitors
- interventionNames
- Biological: Autologous tumor-infiltrating lymphocytes
- Drug: Ipilimumab
- Drug: Nivolumab
- Drug: proleukin
- Drug: Cyclophosphamide
- Drug: Fludara
Primary outcomes (1)
- measure
- Number of Participants and Type of Reported Adverse Events
- timeFrame
- Up to 2,5 years from begin of study
- description
- Determine the safety of the administration of TIL therapy including checkpoint inhibitors, lymphodepleting chemotherapy and Interleukin-2 for patients with cancer by reporting grade \>2 adverse events according to CTCAE v. 4.0
Secondary outcomes (3)
- measure
- Time to Disease Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 \<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.
References
Publications (1)
- DERIVEDKverneland AH, Chamberlain CA, Borch TH, Nielsen M, Mork SK, Kjeldsen JW, Lorentzen CL, Jorgensen LP, Riis LB, Yde CW, Met O, Donia M, Svane IM. Adoptive cell therapy with tumor-infiltrating lymphocytes supported by checkpoint inhibition across multiple solid cancer types. J Immunother Cancer. 2021 Oct;9(10):e003499. doi: 10.1136/jitc-2021-003499. PMID 34607899