Study on KTE-X19 for Patients with Minimal Residual Disease in B-Cell Acute Lymphoblastic Leukemia

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06144606

Provider View

This Phase 2 clinical trial is testing the effectiveness and safety of KTE-X19 CAR T-cell therapy in patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) who are in remission but still have minimal residual disease (MRD).

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well KTE-X19 CAR T-cell therapy works and how safe it is for patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) who are in remission but still have minimal residual disease (MRD). MRD means that a small number of cancer cells remain in the body after treatment, which can be detected through specific tests.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of CD19 positive B-cell acute lymphoblastic leukemia.
  • Have completed and recovered from initial chemotherapy, except for certain conditions like mild nerve damage, diabetes, or low blood cell counts caused by treatment.
  • Be in complete remission with minimal residual disease, meaning fewer than 5% cancer cells in the bone marrow.
  • Be willing to provide written consent to participate in the study.
  • Be able to attend all study visits and follow the study requirements.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate kidney, liver, lung, and heart function.
  • Have sufficient blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use birth control during the study and for six months after treatment.
  • Men and women of childbearing potential must agree to use birth control during the study and for six months after treatment.

Exclusion Criteria

  • Have certain types of leukemia or lymphoma, such as Burkitt's lymphoma or mixed phenotype leukemia.
  • Have an active infection requiring treatment, including HIV, Hepatitis B, or Hepatitis C.
  • Have any condition or treatment that could interfere with the study or is not in the patient's best interest, such as severe heart disease or uncontrolled diabetes.
  • Have had blood clots not related to a central venous catheter within three months before joining the study.
  • Have had a heart attack or other significant heart issues within the past year.
  • Have a history of brain disorders, such as seizures or strokes.
  • Have active leukemia in the central nervous system.
  • Have severe health conditions with a life expectancy of less than six months.
  • Have another active cancer that is not controlled.
  • Have a genetic syndrome that affects bone marrow, like Fanconi anemia.
  • Have a primary immune deficiency or autoimmune disease requiring treatment in the past two years.
  • Be taking corticosteroids or other immunosuppressive drugs within seven days before joining the study.
  • Have any indwelling medical devices, except for certain types of catheters.
  • Have received a live vaccine within four weeks before joining the study.
  • Be pregnant, breastfeeding, or planning to have children during the study and for three months after the last treatment.

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