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Trial record 1 of 1 for:    TILT-123
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TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma (TUNINTIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217473
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
TILT Biotherapeutics Ltd.

Brief Summary:
This is an open-label, phase 1, first-in-human (FIH), dose-escalation, multicenter, multinational trial evaluating the safety of oncolytic adenovirus TILT-123 as monotherapy and in association with T-cell therapy with TILs in metastatic melanoma patients.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: TILT-123 Phase 1

Detailed Description:

The primary objective of the trial is to evaluate the safety of TILT-123. The approach has the potential to a) increase the efficacy of adoptive T-cell therapy, b) remove the need for toxic pre- and post-conditioning regimens, c) yield the combined anti-tumor benefits of armed oncolytic viruses and T-cell therapy.

Dose escalation of TILT-123 injection will take place between cohorts not intra-patient and will be determined based on Dose Limiting Toxicities (DLTs).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, single arm, dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 in Melanoma Patients Receiving Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: TILT-123

Patients will receive administrations of TILT-123. Patients will also receive Tumor Infiltrating Lymphocytes (TILs) during the treatment phase.

Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.

Biological: TILT-123
TNFalpha and IL-2 coding oncolytic adenovirus TILT-123




Primary Outcome Measures :
  1. Number of Participants with any (serious and non-serious) Adverse Events prior to TIL administration. [ Time Frame: 36 days ]
  2. Number of Participants with abnormal laboratory values prior to TIL administration. [ Time Frame: 36 days ]
  3. Number of Participants with vital sign abnormalities prior to TIL administration. [ Time Frame: 36 days ]
  4. Safety assessed by 12- lead electrocardiograms (ECGs) Adverse Events prior to TIL administration. [ Time Frame: 36 days ]
    Any clinically significant adverse changes on the ECG will be reported as Adverse Events.



Information from the National Library of Medicine

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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:

  • Signed and dated informed consent before any trial-related activities.
  • Male or female, between 18-75 years of age (both included).
  • Pathologically confirmed previously treated refractory or recurrent stage 3-4 melanoma, which cannot be treated with curative intent with available therapies.
  • At least one prior line of medical treatment is required (for example checkpoint inhibitors, kinase inhibitors, interleukin-2). Multiple prior therapies (e.g. surgery, checkpoint inhibitors, kinase inhibitors, interleukin-2, interferon, chemotherapy, radiation) are allowed.
  • A > 9 mm tumor (in diameter, typically a minimum of 1 cm3 in volume) without signs of necrosis must be available for biopsy/operation to enable growing of TILs.
  • At least one additional tumor (>14 mm in diameter) must be available for injections and biopsies for correlative analyses. The disease burden must be measurable, but does not need to fulfil RECIST 1.1.
  • Eligible for adoptive T-cell therapy with tumor infiltrating lymphocytes
  • Adequate hepatic, cardiac and renal functions as following:

    • Bilirubin, creatinine (serum), leukocytes, platelets; normal values.
    • Haemoglobin ≥ 100 g/L.
    • AST and ALT < 3 x ULN.
  • Men and women must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 90 days after end of treatment, in accordance with the following:
  • Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be used in addition to one of the following methods: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).
  • Women not of childbearing potential: Barrier contraceptive method (i.e. condom) must be used.
  • Men: Barrier contraceptive method (i.e. condom) must be used.
  • Demonstrated WHO performance score of 0-1 at screening.
  • Life expectancy time longer than 3 months.
  • Capable of understanding and complying with parameters as outlined in the protocol.
  • BRAF negative or positive.

Exclusion Criteria:

  • Use of immunosuppressive medications (corticosteroids or drugs used in treatment of autoimmune disease). Exempted are the following which can be allowed at screening and during the trial: replacement corticosteroids if e.g. the patient has adrenal insufficiency after prior immunotherapy; pulmonal and topical treatments; up to 20 mg of prednisone/prednisolone.
  • History of another active invasive cancer within the past 5 years, except basalioma.
  • Treated with any anti-cancer therapy for melanoma 30 days prior to enrolment. Anti-cancer therapy for melanoma is defined as anti-cancer agents (immunotherapy, signal-transduction inhibitors [e.g. BRAF and MEK inhibitors], cytotoxic chemotherapy), radiotherapy and investigational agents. An investigational agent is any drug or therapy that is currently not approved for use in humans.
  • Uncontrolled cardiac or vascular diseases.
  • History of heart attack or cerebral stroke within the previous 12 months before screening or is not recovered from an older heart attack or cerebral stroke.
  • LDH value > 3 x ULN.
  • History of hepatic dysfunction, hepatitis or HIV.
  • History of coagulation disorder.
  • Any other disease which prevent participation in the opinion of the investigator.
  • Female patients who are pregnant, breastfeeding or intends to become pregnant.
  • Untreated brain metastases. Treated brain metastases which have not progressed in 3 months prior to screening are allowed.
  • Previously treated with any oncolytic adenovirus that was administered intratumorally.
  • Previously treated with adoptive cell therapy.
  • Allergy to TILT-123, TIL, or ingredients present in the investigational medicinal products.
  • Administered an investigational medicinal product or device in another clinical trial within 30 days prior to screening

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): NCT04217473


Contacts
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Contact: Herlev Hospital +45 38 68 38 68 herlevhospital@regionh.dk

Locations
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Denmark
National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University Recruiting
Copenhagen, Denmark
Principal Investigator: Inge Marie Svane         
France
CHU Nantes Not yet recruiting
Nantes, France
Principal Investigator: Brigitte Dréno         
Sponsors and Collaborators
TILT Biotherapeutics Ltd.
Investigators
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Principal Investigator: Inge Marie Svane CCIT, Herlev Hospital, Copenhagen University
Principal Investigator: Brigitte Dréno CHU Nantes, Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TILT Biotherapeutics Ltd.
ClinicalTrials.gov Identifier: NCT04217473    
Other Study ID Numbers: TILT-T215
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TILT Biotherapeutics Ltd.:
oncolytic virus
T-cell therapy
immunotherapy
TILT
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas