A Phase 2 interventional study of Cyclophosphamide and Fludarabine in Kidney Cancers and Renal Cell Carcinoma (Kidney Cancer), sponsored by Beth Israel Deaconess Medical Center. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
This study aims to evaluate autologous ex vivo expanded tumor-infiltrating lymphocyte therapy (lifileucel/LN-145) for kidney cancer after failure of PD-1 blockade.
This is a Phase II single-arm trial of tumor-infiltrating lymphocyte (TIL) therapy in kidney cancer. Briefly, participants who meet eligibility criteria undergo surgical removal of a metastasis or primary tumor to provide material for generation of the TIL product in a lab, which involves growing and expanding the immune cells contained in the tumor before infusing the TIL product into the patient.
Baseline evaluations occur before tumor harvest, and participants who proceed on study undergo tumor resection so tissue can be shipped to a manufacturing facility to create the autologous TIL product LN-145/lifileucel. The treatment plan includes 5 days of lymphodepleting chemotherapy before TIL infusion, using cyclophosphamide and fludarabine, followed by LN-145 infusion on Day 0 and IL-2 (aldesleukin) afterward. The study calendar includes post-treatment visits around Day 14, Day 28, Weeks 8, 12, and 18, then every 3 months starting at Month 6, with long-term follow-up by telephone continuing until study end or withdrawal, up to Month 36. Participants undergo screening and tumor resection to obtain tissue for manufacture of the TIL product. If treatment proceeds, participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by LN-145 infusion and IL-2 (aldesleukin). Participants complete scheduled clinic-based assessments and longer-term follow-up, including telephone follow-up approximately every 3 months for up to about 3 years
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 10 is below the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Compared within Carcinoma, Renal Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Kidney Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
or cytologically confirmed, advanced or renal cell carcinoma with clear cell, papillary, sarcomatoid (with or without other subtypes present), or unclassified histology. Other non-clear cell subtypes are also eligible if the patient has had a prior documented response to therapy.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo tumor resection for TIL manufacturing, then receive lymphodepleting cyclophosphamide and fludarabine, followed byLN-145/lifileucel infusion and IL-2 (aldesleukin), with scheduled post-treatment clinic visits and long-term follow-up
Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Aldesleukin (IL-2) · Procedure: Tumor Resection
Part of the lymphodepleting chemotherapy given before LN-145 infusion
Part of the lymphodepleting chemotherapy given before LN-145 infusion.
Administered after LN-145 infusion as part of the treatment regimen.
Surgical removal of tumor tissue for TIL production/manufacture
Radiographic Objective Response Rate
HCC-centrally assessed Objective Response Rate per RECIST 1.1 of the efficacy evaluable population Primary analysis is performed on patients who receive TIL.
Time frame: Participants will be followed thought out the course of the trial for 3 years
Radiographic change in target lesions
Longitudinal and best change in target lesion measurements. Target lesions are measured at baseline and followed per RECIST 1.1
Time frame: Participants will be followed thought out the course of the trial for 3 years
Radiographic Disease Control Rate (SD + PR + CR)
Disease control rate is listed as a secondary endpoint and will be summarized in the efficacy cohort.
Time frame: Participants will be followed thought out the course of the trial for 3 years
Duration of response
Duration of overall response is measured from the first time CR or PR criteria are met until the first date recurrent or progressive disease is objectively documented, or death due to any cause
Time frame: Participants will be followed thought out the course of the trial for 3 years
Progression-free survival
Progression-free survival is a listed secondary endpoint for both the efficacy evaluable population and the total population. Time-to-event variables are calculated from TIL infusion; PFS is also calculated for the total population from trial enrollment.
Time frame: Participants will be followed thought out the course of the trial for 3 years
Toxicity per CTCAE v6.0
Adverse events are graded using NCI Common Terminology Criteria for Adverse Events version 6.0.
Time frame: Participants will be followed thought out the course of the trial for 3 years
Feasibility
Feasibility is defined as the proportion of patients who successfully undergo tumor harvest, ex vivo TIL expansion, lymphodepletion, and TIL infusion, regardless of number of IL-2 doses given post-TIL.
Time frame: Assessed at time of TIL infusion (D0)
Plan to share: Yes — The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Aug 2029, 27 months later.
Of 183 non-industry phase 2 interventional studies under Carcinoma, Renal Cell, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 98. This study's planned 27 months is below that.
Counting every sponsor, half of 230 studies reached it within 58 months; a quarter within 33 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cyclophosphamide · Fludarabine · Aldesleukin
Beth Israel Deaconess Medical Center →