RecruitingPhase 2NCT06144606

Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

60 participants

Start Date

Dec 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a CAR T-cell therapy called KTE-X19 — in which a patient's own immune cells are re-engineered to attack cancer cells — in adults with B-cell acute lymphoblastic leukemia (B-ALL) who have responded to initial chemotherapy but still show trace amounts of cancer (called minimal residual disease, or MRD). **You may be eligible if...** - You are 18 or older with B-cell acute lymphoblastic leukemia (a type of blood cancer) - You have achieved a complete response to initial chemotherapy, but a bone marrow biopsy shows trace cancer cells (MRD positive) - Your cancer cells test positive for the CD19 marker - You have recovered from side effects of induction chemotherapy - Your heart, lungs, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have a specific type called Burkitt's lymphoma, MLL-rearranged leukemia, or stem cell leukemia - You have an active infection including HIV, Hepatitis B, or Hepatitis C - You have had a heart attack or serious cardiac event in the last 12 months - You have a seizure disorder or have had brain involvement from leukemia - You have another active cancer - You are pregnant or breastfeeding - You have an indwelling drain or catheter (other than approved types) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTecartus

Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06144606


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