[Agni-01] Safety and Efficacy of OBX-115 in Advanced Solid Tumors

A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) in Participants with Advanced Solid Tumors.

OBX-115 is an investigational TIL cell therapy that is genetically modified to produce a cytokine (IL15) that is membrane-bound (not secreted).

This study has a single group assignment:

Experimental - Participants with advanced solid tumors: Participants will receive conditioning therapy prior to administration of OBX-115 regimen. A tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by a short course of acetazolamide.

Inclusion Criteria:

• Participant has a histologically confirmed diagnosis o relapsed refractory metastatic non-small cell lung cancer (NSCLC).
• 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).
• Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.
• After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.

Exclusion Criteria:

• Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are up to 1.5cm in diameter that have been treated, if clinically indicated.
• Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
• Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
• Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.