NCT05868915

HV-101 for Patients With Advanced Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Hervor Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	HV-101	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.

Timeline

• Start date: 2023-08-04
• Primary completion: 2025-05-31
• Completion: 2026-01-15
• First posted: 2023-05-22
• Last updated: 2026-01-21

Locations

1 site across 1 country: China