A Non-Small Cell Lung Cancer Study:
Investigating safety and effectiveness of naturally occurring tumor-targeting immune cells from bone marrow on NSCLC
About the study:
Cancer patients have a natural source of tumor-targeting immune cells in their bone marrow that can fight cancer. By activating and expanding the T cells from this reservoir, we are able to produce Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs®– NSCLC) and use them to potentially fight your cancer.
This study examines MILs®-NSCLC in combination with nivolumab (a PD-1 inhibitor) in patients with locally advanced and unresectable or metastatic NSCLC who have had previous treatment.
Trial Objectives
To see how participant’s cancer responds to the therapy.
To see how well participants tolerate MILs®-NSCLC when given with nivolumab.
Study Participants:
Approximately 20 participants will be treated with MILs®-NSCLC plus nivolumab.
Study Treatments
This study will examine the safety and efficacy of Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs®-NSCLC) combined with nivolumab in participants with locally advanced and unresectable or metastatic NSCLC who were refractory to, or have relapsed on, an anti-PD-1 containing regimen. MILs®– NSCLC are an adoptive cell therapy product derived via the activation and expansion of the T cells from the participant’s bone marrow. Participants will have their bone marrow taken which will be used to manufacture the MILs®-NSCLC.
MILs®-NSCLC, developed from the patient’s bone marrow, will be administered to the patient following manufacturing. Nivolumab will be administered the day following the MILs®-NSCLC administration and every four weeks until treatment discontinuation.
Please find a schematic of the bone-to-vein process below:
Step 1) Bone marrow collected from eligible participant
Step 2) Bone marrow aspirate transported to manufacturing facility
Step 3) MILs®-NSCLC manufactured and frozen
Step 4) MILs®-NSCLC transported to medical facility
Step 5) MILs®-NSCLC infused into patient
About Study Sponsor WindMIL Therapeutics®
At WindMIL Therapeutics®, we are dedicated to our mission: Translating novel insights in bone marrow immunology into life-saving cell therapies for cancer patients.
The bone marrow has an important role in the immune system, acting as a reservoir of persistent immune cells generated as a response to foreign antigens. Our proprietary process creates a cellular product called MILs® (Marrow Infiltrating Lymphocytes) that contains these activated tumor-targeting memory T cells.
We aim to leverage our deep understanding of the unique immunologic properties of the bone marrow to lead the way in cancer cell therapies, but also to fulfill our commitment to helping patients live a longer, healthier life.