Study on Anitocabtagene-autoleucel for Relapsed or Hard-to-Treat Multiple Myeloma (iMMagine-1)

Sponsor: Kite, A Gilead Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05396885

Provider View

This Phase II clinical trial is testing a new CAR-T cell therapy called anitocabtagene-autoleucel for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called anitocabtagene-autoleucel for patients with multiple myeloma that has come back or is not responding to other treatments. The treatment involves using a patient's own immune cells, which are modified in a lab to better target and attack cancer cells. The study includes several steps: screening, enrollment, pre-treatment with chemotherapy, the main treatment with anitocabtagene-autoleucel, and follow-up. If needed, additional therapy may be given to control the disease while the main treatment is being prepared. The effectiveness and safety of the treatment will be checked regularly for up to two years, and long-term safety will be monitored for up to 15 years.

Description

This clinical trial is testing a new treatment for multiple myeloma, a type of blood cancer. The treatment, called anitocabtagene-autoleucel, uses a patient's own T cells, which are a type of white blood cell. These cells are taken from the patient, modified in a lab to better fight cancer, and then given back to the patient. The study is open-label, meaning both the researchers and participants know what treatment is being given. It includes several phases: screening to see if patients qualify, enrollment, pre-treatment with chemotherapy to prepare the body, the main treatment with the modified T cells, and follow-up to monitor results. If necessary, additional therapy may be used to control the cancer while the main treatment is being prepared. The study will assess how well the treatment works and its safety, with regular check-ups for up to two years and long-term safety monitoring for up to 15 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give consent.
  • Have multiple myeloma that has returned or not responded to at least three previous treatments, including specific types of drugs.
  • Have measurable disease based on specific medical tests.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 12 weeks.
  • Have adequate organ function, including:
    • Oxygen levels of at least 92% on room air.
    • Heart function with an ejection fraction of at least 45%.
    • Specific blood cell counts above certain levels.
    • Kidney function with creatinine clearance of at least 45 mL/min.
    • Liver function within specified limits.
    • Blood clotting times within specified limits unless on stable anticoagulation.
  • Have resolved any side effects from previous cancer treatments to a mild level.
  • Agree to use effective birth control during and for 12 months after treatment.
  • Willing to participate in long-term follow-up for up to 15 years.
  • Have a leukapheresis product accepted for cell processing.

Exclusion Criteria

  • Have plasma cell leukemia or a history of it.
  • Have received certain treatments for multiple myeloma within 14 days before cell collection.
  • Be on high-dose steroids or other immunosuppressive therapy within 14 days before cell collection.
  • Have had previous gene therapy or similar treatments.
  • Have had a stem cell transplant within 3 months before cell collection.
  • Have solitary plasmacytomas without other measurable disease.
  • Have allergies to study drug components.
  • Have severe or uncontrolled illnesses, including:
    • Active infections requiring treatment.
    • Severe heart conditions.
    • Significant lung problems.
    • Recent blood clots or bleeding issues.
    • Autoimmune diseases needing treatment in the last 24 months.
  • Test positive for active hepatitis B, C, or HIV.
  • Have active cancer in the central nervous system.
  • Have a history of certain brain conditions.
  • Have another active cancer that required treatment in the last 3 years.
  • Be pregnant or breastfeeding.
  • Have any condition that would prevent participation in the study.
  • Have received a vaccine within 6 weeks before cell collection.
  • Be enrolled in another study for multiple myeloma treatment.

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