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Phase 1 Clinical Trial Launches Combining Cold Exposure and PD-1/PD-L1 Immunotherapy in Solid Tumors

ClinicalTrials.gov·May 28, 2026
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Phase 1 Clinical Trial Launches Combining Cold Exposure and PD-1/PD-L1 Immunotherapy in Solid Tumors
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Research Background

This study is a Phase 1 clinical trial that concurrently administers cold exposure and PD-1/PD-L1 immunotherapy to patients with solid tumors. Preclinical data indicating that cold exposure enhances immune cell activation have prompted investigation in humans.

Cold Exposure Mechanism

Cold exposure induces activation of brown adipose tissue (BAT), thereby modulating metabolic and immune microenvironments. BAT generates heat and increases cytokine secretion, facilitating interactions with immune cells.

Clinical Design and Objectives

The trial is a single‑center, prospective, single‑arm, open‑label study enrolling 24 patients with solid tumors. The primary objectives are to assess safety, tolerability, and feasibility, while secondary objectives explore antitumor activity and changes in immune and metabolic biomarkers.

Expected Impact and Reach

If cold exposure amplifies immune responses, it could broaden the efficacy of existing PD-1/PD-L1 inhibitors. Successful outcomes may position this approach as a platform technology applicable to other cancer types and immunotherapies.

💬Why It Matters

From an investor perspective, the study has the potential to enhance immunotherapy efficacy and increase market valuation. For job seekers and industry professionals, it expands opportunities for developing novel therapeutic platforms.

Source: ClinicalTrials.gov (api_ct)

https://clinicaltrials.gov/study/NCT07538479