What is the Purpose of this Study?
The goal of this study is to determine the recommended dose of an experimental cell therapy called OBX-115 with another medication called acetazolamide (approved by the U.S. Food and Drug Administration as a mild diuretic) that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors or disease-specific drugs. The safety, efficacy (how well the drug works to treat the patient’s cancer), and tolerability of these drugs will also be studied. OBX-115 is made by taking the patient’s own T cells (a type of white blood cell) from tumor tissue and genetically modifying (changing) them to target the cancer cells. Acetazolamide will be given for a short period of time to “activate” OBX-115 and attack the cancer cells. Researchers believe that giving these drugs together may result in less severe side effects and better effectiveness than those seen in other T cell therapies. The combined use of OBX-115 and acetazolamide in this study is considered experimental.
Eligibility
- 1. Participant must be 18 years of age or older at the time of signing the informed consent.
- 2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC).
- 3. Melanoma participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease).
- 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Saba Mukarram
- CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes In Participants with Advanced Solid Tumors