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Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer

NCT05505812 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-18

No results posted yet for this study

Summary

Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced breast cancer.

Conditions

Interventions

BIOLOGICAL

HS-IT101

Adoptive transfer of 1x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes.

Sponsors & Collaborators

  • Qingdao Sino-Cell Biomedicine Co., Ltd.

    collaborator INDUSTRY

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Haibo Wang, MD · The Affiliated Hospital of Qingdao University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-10-08
Primary Completion
2023-12-31
Completion
2027-03-31

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 NCT05505812 on ClinicalTrials.gov