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New treatment option for Recurrence Tumor
Official title Immunotherapy for the Treatment of Advanced Solid Tumor
ClinicalTrials.gov ID: NCT03658785
What this study is testing
What is TIL?
TIL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrence tumor.
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
- The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- To be eligible for the study, patients must meet ALL of the following criteria prior to enrollment in the study:
- Must be ≥ 18 years of age at the time of consent.
- Must have recurrent, metastatic, or persistent carcinoma that is not amenable to curative treatment with surgery and/or radiation therapy and for...
- Must have at least 1 lesion that is resectable for TIL generation. The resected TIL generating lesion(s) should yield at least 1.5 cm in diameter...
- Patients must have progressive disease while receiving or after the completion of the most recent prior treatment.
You likely can't join if
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients who are on a systemic steroid therapy \> 10 mg of prednisone daily or other steroid equivalent.
- Patients who currently have prior therapy-related toxicities greater than Grade 1 according to NCI-CTCAE v4.03; except for peripheral neuropathy...
- Patients who have a contraindication to or history of hypersensitivity reaction to any component or excipients of the TIL therapy and the other study...
- Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory, or immune...
- Patients with symptomatic and/or untreated brain metastases (of any size and any number).
See the full eligibility criteria
- To be eligible for the study, patients must meet ALL of the following criteria prior to enrollment in the study:
- Must be ≥ 18 years of age at the time of consent.
- Must have recurrent, metastatic, or persistent carcinoma that is not amenable to curative treatment with surgery and/or radiation therapy and for which no other therapies are expected to have significant benefit, in the...
- Must have at least 1 lesion that is resectable for TIL generation. The resected TIL generating lesion(s) should yield at least 1.5 cm in diameter post-resection of tumor tissue. Following resection for TIL generation...
- Patients must have progressive disease while receiving or after the completion of the most recent prior treatment.
- Any prior therapy directed at the malignant tumor must be discontinued at least 28 days prior to tumor resection. Radiation therapy may have been received up to 28 days prior to tumor resection for lesions not expected...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must be seronegative for the human immunodeficiency virus (HIV).
- Patients with positive serology for hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), or hepatitis C virus (anti-HCV) indicating acute or chronic infection may be enrolled if the viral...
- Hematology: Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim;White blood cell (WBC) greater than or equal to 3000/mm(3);Platelet count greater than or equal too...
- Chemistry: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to to 2.5 times the upper limit of normal. Serum creatinine less than or equal to to 1.6 mg/dl.Total bilirubin less...
- Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients who are on a systemic steroid therapy \> 10 mg of prednisone daily or other steroid equivalent.
- Patients who currently have prior therapy-related toxicities greater than Grade 1 according to NCI-CTCAE v4.03; except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment/resection.
- Patients who have a contraindication to or history of hypersensitivity reaction to any component or excipients of the TIL therapy and the other study drugs.
- Patients with active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients with symptomatic and/or untreated brain metastases (of any size and any number).
- Patients who have any form of primary or acquired immunodeficiency syndrome, such as severe combined immunodeficiency disease or acquired immune deficiency syndrome (AIDS).
- Patients who have a diagnosis of end-stage renal disorder requiring hemodialysis.
- Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class 2 or higher. Patients who have a forced expiratory volume in 1 second (FEV1) of less than or equal...
- Patients who have received a live or attenuated vaccine within 28 days of the NMA-LD regimen.
- Patients whose cancer requires immediate treatment or who would otherwise suffer a disadvantage by participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. 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.