Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma

This is a double‐arm, single‐center, randomized, open label Phase I clinical trial to evaluate the efficacy and safety of the combination of ex‐vivo expanded allogeneic γδ T cells plus recombinant human interferon α1b or PD‐1 monoclonal antibody in patients with Stage III‐IV resectable melanoma(AJCC 8th). We randomly assigned patients with stage III‐IV melanoma that was amenable to surgical resection to three doses of neoadjuvant γδT cells plus IFN‐α1b or γδT cells plus pembrolizumab , surgery, and 15 doses of adjuvant γδT cells plus IFN‐α1b or γδT cells plus pembrolizumab. The primary endpoints are pathological response rate after 3 cycles of treatment, including: complete pathological response rate (pCR), major pathological response rate (MPR), partial pathological response rate (pPR); preoperative imaging response rate (RECIST v1.1) was evaluated, including complete response (CR), partial response (PR), stable disease (SD), and disease progression (PD); and proportion of patients who do not need surgery due to remission. The second endpoints are event‐free survival (EFS), relapse free survival (RFS), and overall survival (OS, 3 years after surgery). The safety profile of the combined γδT cells/IFN‐α1b regimen and γδT cells/ pembrolizumab regimen will be monitored, we will evaluate the numbers and severity of toxicity per the Criteria for Adverse Events version 5 (CTCAEv) including but not limited to all adverse events (AE), incidence of surgery‐related adverse events, and proportion of inoperable patients (due to disease progression or treatment‐related adverse events).