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Tests treatment safety and results for Epithelial Tumors, Malignant
Official title Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors
ClinicalTrials.gov ID: NCT05141474
What this study is testing
What is NEXTGEN-TIL?
NEXTGEN-TIL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epithelial tumors, malignant.
Also referred to as Tumor-infiltrating Lymphocyte Adoptive Cell Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- in the pretreatment phase:
- Patients must have histologically or cytologically proven metastatic or unresectable solid tumors. The disease must have progressed to at least one...
- Patients must have at least one adequate lesion (primary tumor or metastasis) for resection or biopsy for TIL generation with minimal morbidity...
- Patient must be at least 18 years old at the tissue procurement visit.
- Patient must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
You likely can't join if
- (any phase):
- Patients with symptomatic and/or untreated brain metastases. Note: Patients with definitively-treated brain metastases will be considered for...
- Patients with leptomeningeal carcinomatosis.
- Patients with an active concurrent or history within the past 3 years of invasive malignancy, except for non-melanoma skin cancer, cervical and...
- Patients with an active systemic infection requiring anti-infective treatment within 14 days before preparative lymphodepleting therapy.
- Patients with active hepatitis B or hepatitis C.
See the full eligibility criteria
Who can join
- in the pretreatment phase:
- 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...
- 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...
- Patient must be at least 18 years old at the tissue procurement visit.
- Patient must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
- Patient must be able and willing to comply to the study visit schedule and protocol requirements.
- Patients must have a clinical performance of Eastern Cooperative Oncology Group 0 or 1.
- Patients are considered medically fit enough by investigator to undergo all study procedures and interventions.
- Patients with documented left ventricular ejection fraction (LVEF) of ≥45%.
- 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.
- 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...
- 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...
- Life expectancy ≥6 months.
- 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...
- 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...
- 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...
- Patients must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
- Patients must be able and willing to comply with the study visit schedule and protocol requirements.
- Patients must have a clinical performance of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Patients are considered medically fit enough to undergo all study procedures and interventions and adequate hematological, renal and hepatic functions defined by:
- Haemoglobin ≥9.0 g/dL.
- An absolute neutrophil count ≥1000/mm3 without the support of filgrastim.
- Platelets ≥ 100 x10⁹ /mm3.
- PT and aPTT ≤1.5 x upper limit of normal (ULN, unless receiving therapeutic anticoagulation). people receiving therapeutic anticoagulation (such as low-molecularweight heparin or warfarin) should be on a stable dose.
- AST or ALT ≤3 x ULN. Patients with liver metastases must have AST and ALT ≤5.0 x ULN.
- Total bilirubin \<2 mg/dL. Patients with Gilbert's Syndrome must have a total bilirubin ≤3.0 mg/dL.
- 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...
- Patients must be seronegative for HIV antibody.
- 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)...
- Life expectancy ≥3 months.
- 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...
- 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:
- Women of non-childbearing potential (WONCBP).
- 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 from screening until 6...
- Male Participants: during the treatment period and for at least 2 months after the last dose of study treatment, agreement to:
- Remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom or a contraceptive method that result in a failure rate of \<1% per year, with partners who are WOCBP.
- Refrain from donating sperm during the study.
- Inform if his partner gets pregnant during this time.
- Any toxicity related to prior systemic therapy must have recovered to grade 1 or less according to NCI-CTCAE v5.0 at least 4 weeks before treatment enrollment, except for alopecia, vitiligo, or endocrinopathy managed...
- Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.
What rules you out
- (any phase):
- Patients with symptomatic and/or untreated brain metastases. Note: Patients with definitively-treated brain metastases will be considered for enrollment after discussion with Medical Monitor; if, prior to the start of...
- Patients with leptomeningeal carcinomatosis.
- Patients with an active concurrent or history within the past 3 years of invasive malignancy, except for non-melanoma skin cancer, cervical and bladder carcinoma in situ, good prognosis ductal carcinoma in situ of the...
- Patients with an active systemic infection requiring anti-infective treatment within 14 days before preparative lymphodepleting therapy.
- Patients with active hepatitis B or hepatitis C.
- Patients with active autoimmune disease requiring immunosuppressive treatments.
- Patients with a history of organ or bone marrow transplantation.
- Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- Patients requiring regular treatment with steroids at a dose higher than prednisone 10 mg/day (or equivalent). Note: use of inhaled, topical steroids and use of systemic physiologic corticosteroid replacement therapy...
- Patients with current or history within the last 6 months, as determined by the Investigator, of clinically significant, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac...
- Patients with a history of coronary revascularization or ischemic symptoms.
- History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin)
- Patients with allergies to any of the compounds included in any of the treatment products.
- Patients with contraindications for cyclophosphamide, fludarabine and IL-2 at per protocol doses.
- Patients who have received any approved anti-cancer cytotoxic, anti-angiogenic and ICB therapy including radiotherapy within 4 weeks before preparative lymphodepleting therapy. Exception: palliative radiotherapy for...
- Patients who have received any non-cytotoxic drug and molecular targeted therapy within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).
- Patients who have received any investigational agent within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).
- Patients who have received a live, attenuated vaccination within the 4 weeks before lymphodepleting therapy.
- Patients who have undergone major surgery in the previous 3 weeks before lymphodepleting therapy.
- Patients who have previously received any investigational cell or gene therapies.
- Women of childbearing potential who are pregnant or breastfeeding.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient...
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.