RecruitingPhase 1Phase 2NCT06060613

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

Sponsor

Obsidian Therapeutics, Inc.

Enrollment

208 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Melanoma Metastatic Lung Cancer Metastatic Melanoma Tumor Skin

Summary

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cell therapy called OBX-115 — engineered immune cells designed to attack cancer — in patients with advanced melanoma or non-small cell lung cancer (NSCLC) that has stopped responding to standard immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced melanoma or metastatic non-small cell lung cancer - Your melanoma has progressed after receiving a PD-1/PD-L1 checkpoint immunotherapy drug - Your general health is good enough to receive this intensive therapy **You may NOT be eligible if...** - You have a different type of cancer - Your melanoma has not previously been treated with checkpoint immunotherapy - You have certain autoimmune conditions or other serious medical problems 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

BIOLOGICALOBX-115

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 short courses of acetazolamide.