Study on BOXR1030 T Cells for Treating Advanced GPC3-Positive Solid Tumors

Sponsor: Sotio Biotech Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05120271

Provider View

This clinical trial is testing a new treatment using BOXR1030 T cells to see if it is safe and effective for patients with advanced solid tumors that have a specific marker called GPC3. The study involves several steps, including chemotherapy and monitoring, to determine the best dose for future research.

Patient Parameters

Program Overview

This study is the first to test BOXR1030 T cells in humans. It aims to find out if this treatment is safe and to determine the best dose for patients with advanced solid tumors that are positive for glypican-3 (GPC3). Participants will receive chemotherapy to prepare their bodies before getting the BOXR1030 T cells. The study will take place at multiple centers and will involve close monitoring of participants' health and tumor response.

Description

In this study, participants with advanced solid tumors that express the GPC3 marker will receive a new treatment called BOXR1030 T cells. After signing consent forms and completing initial tests, eligible participants will have their T cells collected through a process called leukapheresis. These T cells will be modified in the lab to create BOXR1030 T cells.

Participants will first undergo a 3-day chemotherapy regimen to prepare their bodies for the new T cells. This involves drugs called fludarabine and cyclophosphamide, which will be given in a hospital setting. After receiving the BOXR1030 T cells, participants will stay in the hospital for 10 days for observation.

For the first 28 days after receiving the T cells, participants must stay within two hours of the study site and will have frequent check-ups to monitor their health and any side effects. They will also need to check their temperature daily and undergo neurological assessments.

The study will continue to monitor participants for six months after treatment, with regular visits to assess the treatment's impact on their tumors. After this period, participants will enter a long-term follow-up phase lasting up to 15 years, with visits every few months to check on their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 to 80 years old
  • Weigh at least 50 kg (about 110 pounds)
  • Have a recent tumor sample showing GPC3 positivity
  • Diagnosed with certain types of advanced cancer, such as liver cancer or lung cancer, that express GPC3
  • Have tried standard treatments without success or cannot tolerate them
  • Expected to live more than 16 weeks
  • Have good organ function and heart health
  • Have a good performance status, meaning they can carry out daily activities with little or no assistance
  • Have at least two sites of cancer, with one measurable by scans
  • Have stopped previous cancer treatments for a specified time before starting the study

Exclusion Criteria

  • Have had previous cell therapies like CAR T-cell therapy
  • Have had a stem cell transplant
  • Have untreated or active brain tumors
  • Have not fully recovered from side effects of previous treatments
  • Plan to use other cancer treatments during the study
  • Have uncontrolled or serious health conditions, such as severe infections or heart problems
  • Have had recent radiation therapy
  • Have another active cancer requiring treatment
  • Have significant heart disease or recent heart events
  • Have an active infection or autoimmune disease requiring treatment

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