💬In plain words
What the trial is, and whether it could suit you
Background:
The presence of T-lymphocytes in resected tumor samples derived from long-term survival patients and the fact that reinvigoration of their functionality through the administration of specific immune-therapies can lead to remarkable antitumor responses supports that lymphocytes play a critical role in cancer immunity.
Adoptive cell therapy using tumor-infiltrating lymphocytes product (TIL-ACT) is a well-established combination therapy currently under study in several world reference centers, using an autologous cell product without genetic modifications. This cell product consists of tumor-infiltrating lymphocytes (TIL), which are collected from the patient and expanded in the lab under specific conditions to enhance its antitumoral efficacy before reinfusion in the same patient. However, this cell product alone does not achieve adequate efficacy, and a combination of both p
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria in the pretreatment phase:
1. Patients must have histologically or cytologically proven metastatic or unresectable solid tumors. The disease must have progressed to at least one standard therapy (including at least one prior line with ICB for the group of patients with tumors where ICB is approved), or the patient is unable/unwilling to receive standard therapy or no standard therapy exists for a particular disease.
2. Patients must have at least one adequate lesion (primary tumor or metastasis) for resection or biopsy for TIL generation with minimal morbidity (preferentially using imaging-guided minimally invasive procedures).
Note: If this lesion was previously irradiated, the lesion must have demonstrated progression prior to resection/biopsy.
3. Patient must be at least 18 years old at the tissue procurement visit.
4. Patient must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
5. Patient must be able and willing to comply to the study visit schedule and protocol requirements.
6. Patients must have a clinical performance of Eastern Cooperative Oncology Group 0 or 1.
7. Patients are considered medically fit enough by investigator to undergo all study procedures and interventions.
8. Patients with documented left ventricular ejection fraction (LVEF) of ≥45%.
9. Patients with documented forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) ≥50% tested by a pulmonary function test.
10. Patients must be seronegative for HIV antibody (patients who are HIV seropositive may be less responsive and more susceptible to toxicities related to this experimental treatment since they may have a decreased immune competence).
11. Patients must be seronegative for active hepatitis B (defined as having a negative hepatitis B surface antigen \[HBsAg\] test), and seronegative for hepatitis C (HCV) antibody. Patients with a history of hepatitis B virus (HBV) infection and having a negative HBsAg test and a positive antibody to hepatitis B surface antigen (HBsAg) are eligible. Patients with the hepatitis C antibody test positive are eligible only if tested for the presence of antigen by RT-PCR and be HCV RNA negative.
12. Life expectancy ≥6 months.
13. Patients who are of childbearing potential (postmenarcheal who has not reached a postmenopausal state and has not undergone surgical sterilization) or have partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 6 months after the last dose of IL-2.
Inclusion Criteria in the treatment phase:
1. The disease must have progressed to the last standard therapy, including at least one prior line with ICB for the group of patients with tumors where ICB is approved, and no subsequent approved therapy is available, or the patients are unable/unwilling to receive standard therapy, or no standard therapy exists for a particular disease.
2. Patients must have a remaining measurable disease as defined by RECIST v. 1.1 criteria following tumor resection/biopsy for NEXTGEN-TIL manufacturing.
Note: Lesions previously irradiated should not be selected as target lesions unless there has been demonstrated progression in those lesions.
3. Patients must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
4. Patients must be able and willing to comply with the study visit schedule and protocol requirements.
5. Patients must have a clinical performance of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
6. Patients are considered medically fit enough to undergo all study procedures and interventions and adequate hematological, renal and hepatic functions defined by:
1. Haemoglobin ≥9.0 g/dL.
2. An absolute neutrophil count ≥1000/mm3 without the support of filgrastim.
3. Platelets ≥ 100 x10⁹ /mm3.
4. PT and aPTT ≤1.5 x upper limit of normal (ULN, unless receiving therapeutic anticoagulation). Subjects receiving therapeutic anticoagulation (such as low-molecularweight heparin or warfarin) should be on a stable dose.
5. AST or ALT ≤3 x ULN. Patients with liver metastases must have AST and ALT ≤5.0 x ULN.
6. Total bilirubin \<2 mg/dL. Patients with Gilbert's Syndrome must have a total bilirubin ≤3.0 mg/dL.
7. Serum creatinine \<1.5 mg/dL or measured creatinine clearance ≥50 ml/min calculated using the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL).
7. Patients must be seronegative for HIV antibody.
8. Patients must be seronegative for active hepatitis B (defined as having a negative hepatitis B surface antigen \[HBsAg\] test), and seronegative for hepatitis C antibody. Patients with a history of hepatitis B virus (HBV) infection and having a negative HBsAg test and a positive antibody to hepatitis B surface antigen (HBsAg) are eligible. Patients with the hepatitis C antibody test positive are eligible only if tested for the presence of antigen by RT-PCR and be HCV RNA negative.
9. Life expectancy ≥3 months.
10. Patients who are of childbearing potential (postmenarcheal who has not reached a postmenopausal state and has not undergone surgical sterilization) or have partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 6 months after the last dose of IL-2.
11. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
1. Women of non-childbearing potential (WONCBP).
2. Women of childbearing potential (WOCBP), who:
i. Agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year
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