Study on the Safety and Effectiveness of HLA-G-Targeted CAR-T Cells IVS-3001 in Patients with Previously Treated Advanced HLA-G-Positive Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05672459

Provider View

This clinical trial is testing a new treatment using CAR-T cells, called IVS-3001, to see if it is safe and effective for patients with advanced solid tumors that are positive for HLA-G and have already been treated with other therapies.

Patient Parameters

Program Overview

This study is a Phase 1/2a trial to evaluate the safety, tolerability, and effectiveness of a new CAR-T cell therapy, IVS-3001, in patients with advanced solid tumors that are HLA-G positive. The trial will assess how well the treatment works in shrinking tumors and its long-term safety. Participants will have their tumors tested for HLA-G expression before joining the study.

Description

The study involves a new CAR-T cell therapy called IVS-3001, which targets a specific protein called HLA-G found on some cancer cells. The trial is divided into two phases:

  • Phase 1: Focuses on determining the safety and best dose of IVS-3001 for patients with solid tumors that have not responded to previous treatments.
  • Phase 2a: Evaluates how well IVS-3001 works in shrinking tumors in patients with specific types of HLA-G positive solid tumors.

The study will also look at how the treatment behaves in the body, its long-term safety, and any changes in immune markers related to the treatment.

Participants will need to meet certain health criteria and provide a tumor sample for testing. The study will involve regular health checks and monitoring to ensure the treatment is safe and effective.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of an advanced solid tumor that is HLA-G positive and has not responded to standard treatments.
  • For Phase 2a, patients will be grouped based on specific cancer types:
    • Clear cell renal cell carcinoma that did not respond to certain inhibitors.
    • Epithelial ovarian carcinoma that did not respond to platinum-based therapy.
    • Other HLA-G positive tumors that did not respond to at least one prior treatment.
  • Tumors must show HLA-G expression.
  • Must have at least one measurable tumor.
  • Life expectancy of more than 12 weeks.
  • Must provide a tumor sample for testing.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have good vein access for blood collection.
  • Must have adequate organ function, including heart, blood, liver, and kidney health.
  • Women must not be pregnant and must agree to use effective birth control during and after the study.
  • Men must agree to use effective birth control during and after the study.

Exclusion Criteria

  • Cannot be receiving immunotherapy at the time of enrollment.
  • Cannot have untreated or progressing brain metastases.
  • Cannot have primary brain tumors or certain brain conditions.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have participated in another drug study recently.
  • Cannot have autoimmune diseases or require immunosuppressive therapy.
  • Cannot have had previous CAR-T cell therapy.
  • Cannot have significant heart disease or recent heart issues.
  • Cannot have had major surgery recently.
  • Cannot have received a live vaccine recently.
  • Cannot be on chronic steroid therapy.
  • Cannot have uncontrolled illnesses or infections.
  • Cannot have active hepatitis B, C, or HIV.
  • Cannot have a history of significant bleeding.
  • Cannot have lung disease causing symptoms.
  • Women cannot be pregnant or breastfeeding.
  • Men cannot plan to father a child during the study.
  • Cannot have a history of another cancer unless it was treated and has not returned.

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