CISH Inactivated TILs in the Treatment of NSCLC (NCT05566223) | Clinical Trial Compass
WithdrawnPhase 1/2
CISH Inactivated TILs in the Treatment of NSCLC
Stopped: No recruitment
United States0Started 2023-02
Plain-language summary
A clinical trial to assess the safety and efficacy of genetically-engineered Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing for the treatment of Metastatic Non-small Cell Lung Cancer (NSCLC).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria (1st Screening prior to Tumor Resection - See below for evaluation of continuing eligibility prior to start of investigational treatment):
* Confirmed histologic diagnosis of either PD-L1 negative or positive metastatic non-small cell lung cancer (NSCLC)
* Candidate to receive 1st line treatment with anti-PD-1/anti-PD-L1 immunotherapy in combination with chemotherapy or be within 6 months (Phase 1) or 3 months (Phase 2) of initiation of this type of systemic treatment (regardless of where such treatment was started) when the tumor resection is performed. Patients who have received adjuvant or neoadjuvant anti-PD-1/anti-PD-L1 immunotherapy and/or chemotherapy can be screened for the trial if they experienced a relapse more than 6 months from the end of their last systemic treatment. The tumor resection for investigational product manufacturing should be undertaken before the initiation of this 1st line therapy; however, patients who have already started their 1st line treatment should have these procedures performed and completed as soon as deemed clinically appropriate, but no later than 6 months (Phase 1) or 3 months (Phase 2) from the start of 1st line treatment. After documented radiographic disease progression on or following this 1st line of treatment, patients will receive investigational product as 2nd line therapy.
* Measurable disease per RECIST v1.1 with at least one lesion identified as resectable for cell therapy manufacturing (minimum volume o…