Actively Recruiting
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
Led by Udai Kammula · Updated on 2025-07-10
59
Participants Needed
1
Research Sites
623 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.
CONDITIONS
Official Title
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma, including cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma
- Locally advanced disease must be unresectable by conventional surgery
- Patients with distant metastases must be resistant to standard therapies like gemcitabine or cisplatin
- Must be co-enrolled on a companion protocol for cell harvest with available TIL cultures
- Patients with up to 3 asymptomatic brain metastases under 1 cm or stable after treatment are eligible
- Age between 18 and 75 years
- Able to understand and sign informed consent
- Performance status of ECOG 0 or 1
- Life expectancy greater than three months
- Patients of child-bearing potential must agree to use birth control during and four months after treatment
- Seronegative for HIV antibody
- Seronegative for hepatitis B antigen and hepatitis C antibody; if hepatitis C positive, must test negative for HCV RNA
- Negative pregnancy test for women of child-bearing potential
- Absolute neutrophil count greater than 1000/mm3 without filgrastim
- White blood cell count at least 3000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin over 8.0 g/dl
- Serum ALT/AST less than or equal to 3.5 times upper normal limit
- Serum creatinine less than or equal to 1.6 mg/dl
- Total bilirubin less than or equal to 2.0 mg/dl, or 3.0 mg/dl if Gilbert's Syndrome
- At least four weeks since prior systemic therapy with toxicity recovered to manageable levels
- Minor surgeries allowed if toxicities recovered to grade 1 or less within 3 weeks
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Any primary immunodeficiency such as Severe Combined Immunodeficiency Disease
- Current opportunistic infections
- Active systemic infections requiring treatment, coagulation disorders, or other major illnesses
- History of major organ autoimmune disease
- Current systemic steroid therapy
- History of severe allergic reactions to study agents
- History of active coronary or ischemic symptoms
- Left ventricular ejection fraction less than or equal to 45%, especially in patients over 65 or with heart arrhythmias or ischemic heart disease
- Forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted in patients with prolonged smoking history or respiratory symptoms
- Use of any other investigational agents during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
J
Josh Tobin
CONTACT
A
Allyson Welsch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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