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 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Biological: TILT-123||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open-label, single arm, dose escalation|
|Masking:||None (Open Label)|
|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|
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.
TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
- Number of Participants with any (serious and non-serious) Adverse Events prior to TIL administration. [ Time Frame: 36 days ]
- Number of Participants with abnormal laboratory values prior to TIL administration. [ Time Frame: 36 days ]
- Number of Participants with vital sign abnormalities prior to TIL administration. [ Time Frame: 36 days ]
- 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.
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
|Contact: Herlev Hospital||+45 38 68 38 email@example.com|
|National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University||Recruiting|
|Principal Investigator: Inge Marie Svane|
|Principal Investigator: Brigitte Dréno|
|Principal Investigator:||Inge Marie Svane||CCIT, Herlev Hospital, Copenhagen University|
|Principal Investigator:||Brigitte Dréno||CHU Nantes, Nantes University Hospital|