Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells with Chemotherapy for Aggressive T Cell Blood Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07137481

Provider View

This clinical trial is testing a new treatment using engineered immune cells from cord blood, combined with chemotherapy, to manage aggressive T-cell blood cancers in patients who are in their first remission.

Patient Parameters

Program Overview

The study aims to find out if a new treatment using specially engineered immune cells, called iC9/CD5CAR/IL-15 NK cells, is safe and effective for patients with aggressive T-cell blood cancers who are in their first remission. The main goal is to see if this treatment can help keep the cancer from coming back for at least one year.

Description

This study is exploring a new treatment approach for aggressive T-cell blood cancers. It involves using immune cells from cord blood that have been genetically modified to better fight cancer cells. These cells, known as iC9/CD5CAR/IL-15 NK cells, are given to patients along with chemotherapy to help prevent the cancer from returning.

The primary goal is to determine if this treatment is safe and can keep the cancer from coming back for at least one year. Researchers will also look at how long the modified cells stay in the body and how they affect the immune system. The study will also assess overall survival rates after one year and monitor any side effects to ensure the treatment is safe.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 80 years.
  • Have a T-cell blood cancer with at least 30% of the cancer cells showing a marker called CD5.
  • Meet specific criteria for certain types of T-cell cancers, such as T-cell acute lymphoblastic leukemia or lymphoma.
  • At least one week since the last chemotherapy session before starting the study treatment.
  • Can continue certain targeted therapies until three days before starting the study treatment.
  • May have received localized radiation therapy.
  • Have a performance status score above 50% on the Karnofsky scale, indicating the ability to carry out daily activities.
  • Have adequate kidney, liver, heart, and lung function as determined by specific medical tests.
  • Able to understand and sign a consent form.
  • Weigh at least 40 kg (about 88 pounds).
  • Both English and non-English speakers can participate.
  • Agree to use effective birth control methods during the study and for a specified time after.
  • Signed consent for long-term follow-up.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have severe side effects from previous treatments.
  • Have uncontrolled infections or active hepatitis B or C.
  • Have HIV with a detectable viral load.
  • Have active neurological disorders or autoimmune diseases.
  • Have cancer that has spread to the brain or spinal cord.
  • Have another active cancer, except for certain treated skin or cervical cancers.
  • Have had major surgery within four weeks before starting the study treatment.
  • Have had a stem cell transplant or donor lymphocyte infusion within 12 weeks before starting the study treatment.
  • Are using other investigational or anti-cancer drugs.
  • Are on systemic steroid therapy or certain immunosuppressive treatments.

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