MedTrace Logo

HV-101 for Patients With Advanced Solid Tumors

NCT05868915 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Hervor Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2025-05-31
Completion
2026-01-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868915 on ClinicalTrials.gov