CAR T-Cell Therapy for B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
This study is testing a new way to create Chimeric Antigen Receptor (CAR) T-cells locally for people with B-Cell Lymphoma or B-Acute Lymphoblastic Leukemia (B-ALL) that has not responded to other treatments. The CAR T-cells are made from your own immune cells using a special device and a lentiviral vector (CAR19). The main goals are to see if we can reliably make these CAR T-cells and if they are safe when given to patients. You may be able to join if you are between 18 and 79 years old and have CD19+ B-cell lymphoma or B-ALL with limited treatment options. The study plans to enroll 30 participants.
- Study design
- This is an interventional study with an unclear phase, aiming to enroll 30 participants. It focuses on the local manufacturing and administration of CAR T-cells.
- What's involved
- You will undergo eligibility checks, provide informed consent, have your cells collected by apheresis, receive chemotherapy, and then receive the CAR T-cell infusion. You will be closely monitored in the hospital for at least 14 days after infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety for up to 15 years after the CAR T-cell administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- John Lister, MD · PRINCIPAL_INVESTIGATOR · AHN
Who to contact
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What this trial measures
- Successful local CAR T-cell manufacturing48 months
To demonstrate the feasibility of reliably producing CD19-targeted CAR T-cells at our site using the Prodigy device.
- Safety of administration15 years
To demonstrate the safety of administering the manufactured product to subjects as measured by adverse events.
- Safety of administration30 days
Cytokine Release Syndrome score
- Safety of administration30 days
Immune Effector Cell Associated Neurotoxicity Syndrome Grading for Adults (score) - A score of 10 represents no impairment, 7-9 grade 1 ICANS, 3-6 grade 2 ICANS, and 0-2 grade 3 ICANS. A score of 0 due to patient being unarousable and unable to perform assessment corresponds to grade 4 ICANS.
- Safety of administration30 days
Immune Effector Cell Associated Encephalopathy Score - A score of 10 represents no impairment, 7-9 grade 1 ICANS, 3-6 grade 2 ICANS, and 0-2 grade 3 ICANS. A score of 0 due to patient being unarousable and unable to perform assessment corresponds to grade 4 ICANS.