Phase I/II Study of Genetically Modified NK Cells for Treating Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06066359

Provider View

This clinical trial is testing a new treatment using genetically engineered NK cells from cord blood to help control multiple myeloma that has returned or is not responding to other treatments. The study aims to find the best dose and see if it can effectively manage the disease.

Patient Parameters

Program Overview

The purpose of this study is to determine the safest and most effective dose of genetically modified NK cells, called NY-ESO-1 TCR/IL-15 NK cells, for patients with multiple myeloma that has come back or is not responding to treatment. The study will also evaluate if this dose can help control the disease.

Description

This study is divided into two parts:

  • Part A: The goal is to find the safest dose of the new NK cell treatment and see if there are any serious side effects in patients with relapsed or hard-to-treat multiple myeloma.
  • Part B: The study will assess how well patients respond to the treatment 90 days after receiving the optimal dose.

Secondary Goals:

  • Evaluate how long patients remain free from disease progression 180 days after treatment.
  • Measure how long the modified NK cells stay active in the body.
  • Conduct detailed studies on the immune system's recovery.
  • Gather initial data on patients' quality of life and experiences.
  • Assess how long the treatment's effects last.

Secondary Endpoints:

  • Disease progression-free rate at 180 days.
  • Track the number of NK cells in the blood over time.
  • Analyze different types of immune cells at various times.
  • Use the PROMIS-29 questionnaire to evaluate quality of life.
  • Measure the duration of the treatment's response.

Eligibility Criteria

Inclusion Criteria

  • Have multiple myeloma with a specific marker (NY-ESO-1) in the tumor sample.
  • Have a specific genetic marker (HLA-A*02:01).
  • Have relapsed or hard-to-treat multiple myeloma with at least four previous treatments, including specific drugs.
  • Have measurable disease based on specific protein levels in blood or urine.
  • Have relapsed or hard-to-treat plasma cell leukemia with at least two previous treatments.
  • Be at least two weeks from the last myeloma treatment before starting chemotherapy.
  • Previous transplants and cell therapies are allowed if not targeting NY-ESO-1.
  • No active or uncontrolled infections at the start of treatment.
  • No recent use of high-dose steroids.
  • No autoimmune diseases affecting the nervous system.
  • Meet specific health criteria, including kidney, liver, heart, and lung function.
  • Be able to provide informed consent.
  • Be between 18 and 80 years old and weigh at least 40 kg.
  • Use effective birth control during and after the study.
  • Agree to long-term follow-up.
  • No live vaccines within 30 days before joining the study.
  • Have adequate bone marrow function without recent transfusions.
  • No recent bridging therapy for myeloma before starting chemotherapy.

Criteria for Cell Infusion:

  • Infusion may be delayed if there are uncontrolled heart issues, low blood pressure needing medication, or active infections.

Exclusion Criteria

  1. None

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