Phase I/II Study of CAR.70-Engineered IL15-Modified Cord Blood NK Cells with Chemotherapy for Treating Relapsed or Resistant Blood Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05092451

Provider View

This clinical trial is exploring the safety of using special immune cells called NK cells, combined with chemotherapy, to treat patients with blood cancers like leukemia, lymphoma, or multiple myeloma that have returned or are not responding to treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if giving patients natural killer (NK) cells, which are immune cells that can attack cancer, along with chemotherapy, is safe for treating blood cancers that have come back or are hard to treat. These NK cells are taken from a donor and modified to better target cancer cells, potentially helping to control the disease.

Description

The main goal of this study is to determine how safe and effective it is to use CAR.70/IL15-modified NK cells from cord blood in patients with blood cancers that have returned or are not responding to treatment. Researchers will also find the best dose for different types of these cancers.

Secondary goals include:

  • Measuring how long the modified NK cells stay active in the patient's body.
  • Conducting detailed studies on how the patient's immune system recovers after treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a blood cancer with at least 10% of cells showing a specific marker (CD70) in tests.
  • Meet specific criteria for the type of blood cancer.
  • At least 3 weeks since last chemotherapy before starting new treatment.
  • Can continue certain targeted therapies until 3 days before new treatment.
  • Can have localized radiation to some cancer sites before treatment if other sites are untreated.
  • Have a performance status score above 50%.
  • Have good organ function:
    • Kidneys: Creatinine ≤ 1.5 mg/dL and eGFR ≥ 30 ml/min/1.73 m2.
    • Liver: ALT/AST ≤ 2.5 times normal, bilirubin ≤ 1.5 mg/dL (or ≤ 3.0 mg/dL for Gilbert's Syndrome).
    • Heart: Ejection fraction ≥ 50%, no significant heart issues.
    • Lungs: Oxygen saturation > 92%, good lung function.
  • Able to give written consent.
  • Aged 18-75 years.
  • Weigh at least 40 kg.
  • Use effective birth control during and for 3 months after the study.
  • Agree to long-term follow-up.

Exclusion Criteria

  • Positive pregnancy test in women who can have children or are breastfeeding.
  • Significant side effects from previous treatments.
  • Uncontrolled infections.
  • Detectable HIV viral load.
  • Active neurological disorders.
  • Active autoimmune disease in the past year.
  • Conditions like amyloidosis or POEMS syndrome.
  • Cancer affecting the brain or spinal cord.
  • Active graft-versus-host disease.
  • Other active cancers, except certain skin or cervical cancers.
  • Serious medical conditions that could be risky.
  • Major surgery within 4 weeks before starting treatment.
  • Recent stem cell transplant or donor lymphocyte infusion.
  • Use of other experimental or anti-cancer drugs.
  • Taking systemic steroids or certain immune therapies close to enrollment.

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