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NOT YET RECRUITING
NCT06212388
EARLY_PHASE1

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

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells combined with recombinant human interferon-α1b (IFN-α1b) or PD-1 monoclonal antibody in neoadjuvant treatment of patients with Stage III-IV resectable melanoma.

Official title: Efficacy and Safety of Allogeneic γδ T Cells (γδ T Cells) Combined With Interferon-alpha1b (IFN-α1b) or PD-1 Monoclonal Antibody in Neoadjuvant Treatment of Stage III-IV Resectable Melanoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-01-24

Completion Date

2028-10-30

Last Updated

2024-01-25

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Ex-vivo expanded allogeneic γδ T cells

Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

DRUG

Recombinant human interferon α1b

Recombinant human interferon α1b is a protein with potent antiviral, antiproliferative and immunomodulatory properties.

DRUG

Pembrolizumab

Pembrolizumab is a recombinant, humanized programmed death receptor (PD-1) monoclonal antibody that binds to PD- and prevents binding of PD-1 with programed death ligands 1 (PD-L1) and PD-L2. It can function to activate cytotoxic T lymphocytes and inhibit tumor growth.