Actively Recruiting
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
Led by Udai Kammula · Updated on 2025-07-10
240
Participants Needed
1
Research Sites
969 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR).
CONDITIONS
Official Title
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable locally advanced, recurrent, or metastatic cancer of specified types including gastric/esophagogastric, colorectal, pancreatic, sarcoma, mesothelioma, neuroendocrine, squamous cell, Merkel cell, mismatch repair deficient or microsatellite unstable cancers
- Patients with locally advanced disease must be unresectable by conventional surgery
- Patients with distant metastases must have received approved first-line systemic therapies if eligible
- Co-enrollment on companion protocol HCC 17-220 with available TIL cultures
- Up to 3 brain metastases less than 1 cm and asymptomatic, or resected brain metastases, are allowed
- Age between 18 and 75 years
- Able to understand and sign informed consent
- ECOG performance status 0 or 1
- Life expectancy greater than 3 months
- Willingness to use birth control if of child-bearing potential during and up to 4 months after treatment
- Seronegative for HIV, hepatitis B antigen, and hepatitis C antibody (with additional testing if antibody positive)
- Negative pregnancy test for women of child-bearing potential
- Adequate blood counts and organ function as specified
- At least 4 weeks since prior systemic therapy with recovered toxicities, except alopecia or vitiligo
- Minor surgeries allowed if toxicities have recovered to grade 1 or less
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Primary immunodeficiency disorders
- Current opportunistic or active systemic infections requiring treatment
- Clinically significant coagulation disorders
- Major medical illnesses deemed significant by physician
- History of major organ autoimmune disease
- Concurrent systemic steroid therapy
- Severe hypersensitivity to study agents
- Active coronary or ischemic symptoms
- Left ventricular ejection fraction less than or equal to 45% (with specific testing criteria)
- Lung function (FEV1) less than or equal to 60% predicted in patients with smoking history or respiratory symptoms
- Receiving other investigational agents
AI-Screening
AI-Powered 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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