Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

This study is testing a treatment for advanced biliary tract cancers, including cholangiocarcinoma and gallbladder cancer. It uses your own immune cells, called Tumor Infiltrating Lymphocytes (TIL), which are grown in a lab and then given back to you through an IV. This is followed by a drug called aldesleukin. The main goal is to see how many patients have their tumors shrink or disappear (Objective Response Rate). You might be able to join if you are between 18 and 75 years old, have advanced biliary tract cancer that cannot be removed by surgery, and are healthy enough to receive the treatment. The current status of this study is unclear.

Study design: This is a Phase 2 study involving a small number of participants (planned enrollment of 4). It is an interventional study, meaning you will receive a specific treatment.
What's involved: First, a tumor sample will be taken to grow your TIL cells. Once your cells are ready, you will receive chemotherapy, followed by the TIL infusion and then aldesleukin.
Compensation: Not stated in the trial record.
Follow-up: Your response to treatment will be measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

Active, Not Recruiting

PHASE2Ages 18–75InterventionalTreatment

Udai Kammula

~4 participants

Updated 2026-06-01 on ClinicalTrials.gov

What's tested:Tumor Infiltrating Lymphocytes (TIL)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Objective Response Rate (ORR)

Measured over Up to 24 months

Conditions

Biliary Tract Cancer

Cholangiocarcinoma

Biliary Tract Neoplasms

Where it's being run

1 sites across 1 states

Pennsylvania1

Study leadership

Udai S Kammula,, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).

Patients with locally advanced disease should be unresectable by conventional surgical approaches.

Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as gemcitabine, cisplatin, or equivalents) if they are eligible to receive these treatments.

Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy.

Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.

Greater than or equal to 18 years of age and less than or equal to age 75

Able to understand and sign the Informed Consent Document

Clinical performance status of ECOG 0 or 1

Life expectancy of greater than three months

Patients of both genders who are of child-bearing potential must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment.

Serology:

Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)

Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.

Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.

Hematology

Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim

WBC ≥ 3000/mm3

Platelet count ≥ 100,000/mm3

Hemoglobin \> 8.0 g/dl

Chemistry

Serum ALT/AST ≤ to 3.5 times the upper limit of normal

Serum creatinine ≤ to 1.6 mg/dl

Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a clinically manageable level (except for toxicities such as alopecia or vitiligo). (Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less)

Exclusion

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses.

History of clinically significant major organ autoimmune disease

Concurrent systemic steroid therapy.

History of severe immediate hypersensitivity reaction to any of the agents used in this study.

History of active coronary or ischemic symptoms.

Documented LVEF of less than or equal to 45%; note: testing is required in patients with:

Age \> 65 years' old

Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, chest pain.

Documented FEV1 less than or equal to 60% predicted tested in patients with:

A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).

Symptoms of respiratory dysfunction

Patients who are receiving any other investigational agents.

What this trial measures

Objective Response Rate (ORR)Up to 24 months
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. The appearance ≥1 new lesion(s) is considered progression.. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD.

Trialytics