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Clinical Trial 19837

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT04052334

Phase: Phase I
Principal Investigator: Mullinax, John

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Study Title

Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients with Soft Tissue Sarcoma


This is a single-arm trial that will evaluate the feasibility and toxicities of the Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo following treatment.


The primary objective of this study will be to determine whether patients receiving adoptively transferred, tumor specific T cells after non-myeloablative, lymphodepleting chemotherapy followed by high dose IL-2 have acceptable side effects. Secondary objectives will include degree of sustained persistence of infused T cells and objective anti-tumor responses by RECIST v1.1 evaluations for tumor response





IL-2 (Interleukin-2); MESNA (); TIL (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • 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 be eligible
  • 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) >Pulmonary function tests should be completed 65% or FVC > 65% of predicted are required.
  • Adequate renal, hepatic, and hematologic function, including creatinine of >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.

  • Exclusion Criteria

  • 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 (PCR).
  • 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 excluded
  • 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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.