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LTX-315 and Adoptive T-cell Therapy in Advanced Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT03725605
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Lytix Biopharma AS

Brief Summary:
This 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Combination Product: LTX-315 and TILs Phase 2

Detailed Description:
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, 4 doses of LTX-315 will be administered intratumorally over a two 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 induction regimen. The safety and efficacy of the LTX-315 and TIL treatment will be assessed. Patients will be followed up for 15 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: LTX-315 and TILs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase II Single Centre Study Investigating the Safety and Efficacy of LTX-315 and Adoptive T-cell Therapy in Patients With Advanced/Metastatic Soft Tissue Sarcoma
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LTX-315 plus TIL infusion
LTX-315 intratumoural 5mg per injection time point per dosing, TILs expansion and infusion
Combination Product: LTX-315 and TILs
intratumoural injection of LTX-315 and infusion of TILs




Primary Outcome Measures :
  1. Quantification of T-cell level in tumour tissue [ Time Frame: Up to 10 weeks ]
    Evaluate ability of LTX-315 to induce T-cell infiltration

  2. Adverse Event Profile [ Time Frame: Up to 15months ]
    Evaluate safety of LTX-315 as part of the adoptive T-cell therapy throughout treatment period


Secondary Outcome Measures :
  1. Change in T-cell level from baseline in tumour tissue [ Time Frame: Up to 10 weeks ]
    To determine degree of T-cell infiltration of injected lesion following LTX-315 injection

  2. CD8+ T-cell expansion [ Time Frame: Up to 10 weeks ]
    To assess the ability of LTX-315 to expand CD8+ T-cells from tumour tissue

  3. Response Rates [ Time Frame: To 15 months ]
    To assess anti tumour effect of LTX-315 as part of adoptive transfer T-cell therapy


Other Outcome Measures:
  1. Tumour specific antigens in tumour tissue and peripheral blood [ Time Frame: To 15 months ]
    Tumour antigen specificity



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced/metastatic soft tissue sarcoma that has progressed on or after 1 line of systemic treatment
  • 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 t 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 partcular 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725605


Contacts
Contact: Hamina Patel, MD +44 7810891234 hamina.patel@lytixbiopharma.com

Locations
Denmark
Herlev Hospital Recruiting
Copenhagen, Denmark, DK-2730
Contact: Inge Marie Svane, MD         
Sponsors and Collaborators
Lytix Biopharma AS
Herlev Hospital
Investigators
Principal Investigator: Inge Marie Svane, MD Herlev Hospital

Responsible Party: Lytix Biopharma AS
ClinicalTrials.gov Identifier: NCT03725605     History of Changes
Other Study ID Numbers: C17-315-04
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms