LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: LTX-315 and TILs
Intervention description: Intratumoural injection of LTX-315 and infusion of TILs
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: LTX-315 and TILs
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      ATLAS-IT-04 is a two part, single arm study designed to determine the safety and
      effectiveness of LTX-315 to induce T-cell infiltration prior to TIL expansion in patients
      with soft tissue sarcoma. Following intratumoural injection of LTX-315 to a selected lesion,
      the lesion will be extracted for T-cell culture, expansion and infusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced/metastatic soft tissue sarcoma that is stable or has progressed on or after
             minimum 1 line of systemic treatment of advanced/metastatic disease

          -  At least 1 index lesion accessible for injection

          -  At least 1 measurable non-injected lesion that can be used for response willing to
             undergo repeat biopsy and tumour resection procedures

          -  Age between 18 and 75 years

          -  ECOG performance status of 0-1

          -  Meet following blood laboratory criteria: ANC >/= 1.5, Platelet count >/=75, -
             Haemoglobin >/=6mmol/L, AST and ALT </=2.5 x ULN, Creatinine </=1.5 ULN

          -  Willing to comply with the protocol requirements and follow-up

          -  Signed informed consent

        Exclusion Criteria:

          -  A history of clinically significant active systemic autoimmune disease requiring anti
             inflammatory or immunosuppressive therapy within the last 3 months

          -  Other active malignancy within the previous 5 years except for carcinoma in situ of
             cervix, ductal r lobular carcinoma in situ of the breast

          -  Received an investigational drug within 4 weeks prior to receipt of study drug

          -  Received external radiotherapy or cytotoxic chemotherapy within 4 weeks prior to
             LTX-315 administration or have not recovered from AEs (to</= grade 1) Palliative
             radiotherapy to non target and lesions planned for LTX-315 injection within 4 weeks of
             LTX-315 administration is allowed

          -  Currently taking any agent with a known effect on the immune system. Stable doses of
             corticosteroids(up to 10mg prednisolone or equivalent) are permitted for at least 2
             weeks prior to LTX-315 administration

          -  Any serious illness or medical condition such, but not limited to: uncontrolled
             infection or infection requiring antibiotics, uncontrolled cardiac failure,
             uncontrolled systemic and gastrointestinal inflammatory conditions, bone marrow
             dysplasia

          -  Known to test positive for HIV/AIDs, syphilis, human T-cell leukemia-lymphoma virus,
             active Epstein Barr, hepatitis B or C.

          -  history of cerebro- or cardio-vascular disorders and would be of particular risk of
             sequelae following a hypotensive episode

          -  If of child bearing potential, not willing to use effective form of contraception

          -  Breastfeeding and/or have a positive pregnancy test

          -  Donate sperm from start to 3 months after study treatment

          -  Expected to need any other anticancer treatment or immunotherapy during the treatment
             period

          -  Clinically active or unstable central nervous system metastases