This is a single-arm trial that will evaluate the safety and feasibility of the
Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo
- Participants must fulfill all of the following criteria to be eligible for the study
at the time of tumor resection and initiation of TIL expansion.
- Stated willingness to comply with all study procedures and availability for the
duration of the study
- Participants must have metastatic, high-grade soft tissue sarcoma, all subtypes will
- Residual measurable disease after resection of target lesion(s) for TIL growth
- Eastern Cooperative Oncology Group (ECOG) 0 to 1. ECOG performance status of 0 to 1
will be inferred if the patient's level of energy is ≥ 50% of baseline.
- Participants must have progressed on at least one prior standard of care treatment
regimen for metastatic disease.
- A negative pregnancy test (urine or serum) must be documented at screening for women
of childbearing potential.
- A MUGA scan (ejection fraction > 50% is required) ≤ 6 months prior to lymphodepletion.
- Pulmonary function tests should be completed ≤ 6 months prior to lymphodepletion and
forced expiratory volume (FEV1) > 65% or FVC > 65% of predicted are required
- Adequate renal, hepatic, and hematologic function, including creatinine of ≤ 1.7
gm/dL, total bilirubin ≤ 2.0 mg/dL, except in patients with Gilbert's Syndrome who
must have a total bilirubin less than 3.0 mg/dL, AST and ALT of less than 3 X
institutional upper limit of normal, hemoglobin of 8 gm/dL or more, white blood cells
of 2000 per mm^3 and total granulocytes of 750 per mm^3 or more, and platelets of 50
000 per mm^3 or more.
- Participants must have a positive screening EBV antibody titre on screening test.
- Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the
participant agrees to continue to use a method of contraception throughout the study
such as: barrier (i.e. condom, diaphragm), hormonal, IUD, or sponge plus spermicide.
- Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the
institutional upper limit of normal
- Participants with echocardiogram (EKG) within 14 days of initiation of chemotherapy
demonstrating no new rhythm, axis, or ST segment
- Urinalysis within 14 days demonstrating no evidence of a urinary tract infection.
- Participants with active systemic infections requiring intravenous antibiotics,
coagulation disorders, or other major medical illnesses of the cardiovascular,
respiratory, or immune system are excluded.
- Participants testing positive for HIV titer, hepatitis B surface antigen, human T-cell
leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and
fluorescent treponemal antibody (FTA) are excluded. Participants with hepatitis C
antibody must have a negative (undetectable) viral load by polymerase chain reaction
- Participants who are pregnant or nursing are excluded.
- Participants needing chronic immunosuppressive systemic steroids are excluded
- Participants with autoimmune diseases that require immunosuppressive medications are
- Presence of a significant psychiatric disease, which in the opinion of the principal
investigator or his designee, would prevent adequate informed consent or render
immunotherapy unsafe or contraindicated
- Participants with central nervous system metastases will be excluded.
- Inability to comprehend and give informed consent