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CAR T-cell Therapy
TIL Therapy for Biliary Tract Cancer
Phase 2
Recruiting
Led By Udai S Kammula,, MD
Research Sponsored by Udai Kammula
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for people with biliary tract cancer. The treatment involves a non-myeloablative lymphodepleting preparative regimen, infusion of autologous TIL, and high-dose aldesleukin.
Who is the study for?
This trial is for adults aged 18-75 with advanced, recurrent, or metastatic biliary tract cancers who have not responded to standard treatments. They must be able to handle specific chemotherapy and high-dose aldesleukin, sign informed consent, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and agree to birth control measures. Those with small, stable brain metastases may qualify.Check my eligibility
What is being tested?
The study tests the effectiveness of Tumor Infiltrating Lymphocytes (TIL) therapy combined with a non-myeloablative lymphodepleting regimen followed by high-dose aldesleukin in patients with biliary tract cancer. It's a Phase 2 trial aiming to see if this approach can shrink tumors in those who haven't had success with other treatments.See study design
What are the potential side effects?
Potential side effects include reactions from the immune system due to TIL infusion and high-dose aldesleukin such as flu-like symptoms, fatigue, rash, possible organ inflammation and risk of infection. The preparative chemotherapy could also cause typical chemo-related side effects like nausea, hair loss and blood cell count decreases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am enrolled in HCC 17-220 and have TIL cultures ready for therapy.
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My cancer has spread and does not respond to standard treatments like gemcitabine or cisplatin.
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I have advanced or spreading cancer in my bile ducts, gallbladder, or nearby areas.
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My cancer has spread and does not respond to standard treatments like gemcitabine or cisplatin.
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My local cancer cannot be removed with standard surgery.
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My cancer cannot be removed with standard surgery.
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I am between 18 and 75 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am enrolled in HCC 17-220 and have TIL cultures ready for therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Complete response rate (CRR)
Disease control rate (DCR)
Duration of Response (DOR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tumor Infiltrating Lymphocytes (TIL)Experimental Treatment1 Intervention
Patients with locally advanced, recurrent, or metastatic biliary tract cancers will receive the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of up to 2x10^11 lymphocytes infused intravenously through a central vein catheter and Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses.
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Who is running the clinical trial?
Udai KammulaLead Sponsor
2 Previous Clinical Trials
287 Total Patients Enrolled
Udai S Kammula,, MDPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction to any of the medications used in this study in the past.I agree to use birth control during and up to four months after the study.You are not currently taking any other experimental drugs or treatments.I am enrolled in HCC 17-220 and have TIL cultures ready for therapy.My cancer has spread and does not respond to standard treatments like gemcitabine or cisplatin.I have advanced or spreading cancer in my bile ducts, gallbladder, or nearby areas.You are expected to live for at least three more months.My cancer has spread and does not respond to standard treatments like gemcitabine or cisplatin.I do not have any active infections, bleeding disorders, or major illnesses.My lung function is reduced, I've smoked heavily, and I have breathing problems.I have a history of a serious autoimmune disease affecting major organs.My local cancer cannot be removed with standard surgery.I do not have any current infections that could weaken my immune system.I am currently taking steroid medication.I have up to 3 small, symptom-free brain tumors or have had brain surgery.My cancer cannot be removed with standard surgery.I have up to 3 small, symptom-free brain tumors or have had brain surgery.I am between 18 and 75 years old.I am fully active or restricted in physically strenuous activity but can do light work.My heart's pumping ability is reduced (LVEF ≤ 45%).I am enrolled in HCC 17-220 and have TIL cultures ready for therapy.I have had symptoms of heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Tumor Infiltrating Lymphocytes (TIL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participant enrollment for this trial?
"Affirmative. According to clinicaltrials.gov, this study was first published on February 19th 2019 and recently updated on July 21st 2022. The research requires 59 volunteers from 2 medical centres for enrollment purposes."
Answered by AI
How efficacious is Tumor Infiltrating Lymphocytes (TIL) in providing a safe therapeutic option?
"Despite being in a Phase 2 trial with limited data surrounding efficacy, the safety of Tumor Infiltrating Lymphocytes (TIL) was assessed to merit a score of 2."
Answered by AI
Are new participants still being enrolled for this research project?
"As per the details registered on clinicaltrials.gov, this research trial is currently in search for suitable participants. The medical experiment was initially advertised on February 19th 2019 and most recently amended on July 21st 2022."
Answered by AI
Is enrollment exclusive to participants over the age of 75 or are those younger than that eligible as well?
"This clinical trial specifies that participants must be aged 18 or above and no older than 75."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
UPMC Hillman Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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