RecruitingPhase 2NCT05878028

L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

L-TIL Plus Tislelizumab as Second Line Therapy for PD-1 Inhibitor Resistant Advanced NSCLC Patients


Sponsor

Quanli Gao

Enrollment

33 participants

Start Date

Sep 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. However, there is no standard regimen for the patients who refractory from the first-line PD1 inhibitor based therapy. The main questions they aim to answer are: 1.The efficacy of Liquid Tumor Infiltrating Lymphocytes (L-TIL) plus Tislelizumab and Docetaxel for patients failure from first line chemotherapy and PD1 inhibitor therapy. 2. The safety of L-TIL plus Tislelizumab and Docetaxel as second line therapy. All participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab treatment except for disease progression, intolerable toxicity, withdrawal informed consent, death and so on.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of tumor-infiltrating lymphocytes (TILs) — immune cells taken from the patient's own tumor — plus a checkpoint immunotherapy drug called tislelizumab, in people with advanced non-small cell lung cancer (NSCLC) whose cancer stopped responding to a prior PD-1 antibody immunotherapy. **You may be eligible if...** - You have been diagnosed with stage IV non-small cell lung cancer confirmed by biopsy - Your cancer progressed during or after a prior anti-PD-1 immunotherapy - Non-squamous cancer patients must have no EGFR, ALK, ROS1, RET, or MET mutations - You have at least one measurable tumor on scans - Your general health is good (ECOG 0–1) - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - Your cancer is small cell lung cancer or mixed type including small cell - You have had another cancer diagnosis within the past 5 years - You are currently in another clinical trial - You have active autoimmune disease or are on steroids/immunosuppressants - You have organ transplant history or active hepatitis B/C - You are pregnant or breastfeeding - You have symptomatic brain metastases or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTL-TIL, Tislelizumab, Docetaxel

PD1 positive lymphocytes were collect, isolated, and expanded from peripheral blood, then infused back into the patient's body. Besides this, Tislelizumab and Docetaxel were used as combination therapy.


Locations(1)

No.127 Dongming Road

Zhengzhou, Henan, China

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NCT05878028


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