LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma (ATLAS-IT-04)

Launched by LYTIX BIOPHARMA AS · Oct 29, 2018

Keywords

ClinConnect Summary

Patients with advanced/metastatic tumours who have received at least one approved standard of care treatment will be recruited. All patients must have at least two lesions, one that can injected with LTX-315 and another that can used to assess response. In the first part of the study, LTX-315 will be administered intratumorally on 4-6 dosing days over a 2-4 week period to an index lesion which will be biopsied or removed after treatment for T-cell expansion. The second part will involve culturing and expanding T-cells for infusion of tumour infiltrating lymphocytes (TILs) following an induc...

Gender

ALL

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