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Adoptive Transfer of TIL for Advanced Solid Cancers

This study is testing a treatment called Tumor Infiltrating Lymphocytes (TIL) for people with advanced gastric, colorectal, pancreatic, sarcoma, or mesothelioma cancers. TIL are special immune cells taken from your own tumor, grown in a lab, and then given back to you through an IV. Before receiving TIL, you will get a combination of two drugs, Fludarabine and Cyclophosphamide, to prepare your body. After the TIL infusion, you will also receive Aldesleukin, another medication. Researchers want to see how many people respond to this treatment, measured at 24 months. You may be able to join if you are between 18 and 75 years old and have one of the listed cancer types that is locally advanced, recurrent, or has spread.

Study design
This is a Phase 2 study involving about 20 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would undergo a procedure to remove a piece of your tumor. You would also receive intravenous infusions of TIL and Aldesleukin, and a combination of Fludarabine and Cyclophosphamide.
Compensation
Not stated in the trial record.
Follow-up
The main measure of success will be checked at 24 months, suggesting follow-up for at least that long.

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NCT03935893

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

Active, Not Recruiting
PHASE2Ages 18–75InterventionalTreatment
Udai Kammula
~20 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Tumor Infiltrating Lymphocytes (TIL)Fludarabine + Cyclophosphamide combination

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 24 months

Conditions

Gastric Cancer
Colorectal Cancer
Pancreatic Cancer
Sarcoma
Mesothelioma
Neuroendocrine Tumors
Squamous Cell Cancer
Merkel Cell Carcinoma
Mismatch Repair Deficiency
Microsatellite Instability

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Colorectal CarcinomaGastric CarcinomaMerkel Cell CarcinomaMesothelial NeoplasmNeuroendocrine NeoplasmPancreatic CarcinomaSarcomaSolid NeoplasmSquamous Cell CarcinomaMRC1 wt AlleleMSI1 Gene

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?

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Eligibility criteria

Inclusion

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
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.
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
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.

Exclusion

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

What this trial measures

  • Objective Response Rate (ORR)24 months

    Number of patients with Complete Response (CR) + Number of patients with Partial Response (PR) / total number of patients (# with CR + # with PR + # with SD + # with PD), per RECIST v1.1: CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: ≥ 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease (PD): ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance ≥1 new lesion(s) is considered progression.