Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lung Cancer
- Lung Cancer Metastatic
- Lung Cancer - Non Small Cell
- Non -Small Cell Lung Cancer
- Non Small Cell Lung Cancer Metastatic
- NSCLC
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: In Part 1, approximately 3-6 subjects will be treated with MILs™ - NSCLC alone. Following Part 1, approximately 20 subjects will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will examine the safety and efficacy of Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs™ - NSCLC) combined with nivolumab with or without tadalafil in subjects with locally advanced and unresectable and metastatic NSCLC who were refractory to, or have relapsed on, an anti...
This study will examine the safety and efficacy of Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs™ - NSCLC) combined with nivolumab with or without tadalafil in subjects with locally advanced and unresectable and 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 bone marrow T cells. Subjects will have bone marrow harvested during the Screening Period which will be used to manufacture the MILs™ - NSCLC. The MILs™ - NSCLC will then be administered on Day 0. Nivolumab will be administered on Day 1 and will continue every four weeks until treatment discontinuation. Tadalafil will be administered on Day 1 and will continue daily until treatment discontinuation.
Tracking Information
- NCT #
- NCT04069936
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Not Provided
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