NCT05868915

A Phase I/II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of HV-101 Injection for the Patients With Recurrent or Metastatic Solid Tumors

Study Summary

Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers. Objective: To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors. Eligibility: Adults aging 18-75 with advanced solid tumors Design: 1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. 2. Freshly resected patient tumors were dissected by the surgeon. 3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded. 4. HV-101 will be re-infused into the patient.

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Interventions

HV-101BIOLOGICAL
Biological: HV-101 HV-101 is autologous tumor-infiltrating lymphocyte cells without genetic modification. Drug: IL-2 Following cell infusion, the patient receives intravenous IL-2. Drug: Fludarabine Part of the non-myeloablative lymphocyte-depleting preparative regimen. Drug: Cyclophosphamide Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Study Locations

FacilityCityStateCountry
Renmin Hospital of Wuhan UniversityWuhanHubeiChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026