CD22 CAR T-cells for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:
Acute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells. CAR T-cell therapy that targets a marker called CD19 has been show to can cure ALL in many children and adults. But in about 50% of patients, the ALL comes back within a year. Researchers want to find out if a second treatment with CAR T-cell therapy that targets a different marker, CD22, can keep the cancer away longer.
Objective:
To see if CD22 CAR T-cell therapy can keep ALL away longer.
Eligibility:
People aged 3 to 65 years who have no signs of cancer after CD19 CAR T-cell treatment for ALL.
Design:
Participants will be screened. They will have imaging scans and tests of their heart function. A sample of tissue (biopsy) will be collected from their bone marrow. They will have a fluid sample collected from the area around their spinal cord.
Participants will undergo collection of their white blood cells (T cells) during a procedure called leukapheresis. Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create CD22 CAR T-cell therapy.
Participants will take drugs over 4 consecutive days to prepare their body for the CAR T-cell therapy; then they will receive their modified T cells through a tube inserted into a vein. Some people may need to stay in the hospital during treatment.
Participants will have follow-up visits for 2 years.
Who Is on the Research Team?
Sara K Silbert, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for people aged 3 to 65 with B-cell Acute Lymphoblastic Leukemia (ALL) who've had CD19 CAR T-cell treatment and are currently cancer-free. They shouldn't be planning a stem cell transplant, must have good organ function, and no ongoing complications from previous treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Cell Preparation
Participants undergo leukapheresis to collect T cells, which are then modified in a lab to create CD22 CAR T-cell therapy
Lymphodepleting Chemotherapy
Participants receive a 4-day lymphodepleting preparative regimen including fludarabine and cyclophosphamide
CD22 CAR T-cell Infusion
Participants receive their modified T cells through a tube inserted into a vein
Short-term Safety Monitoring
Participants are monitored for short-term safety, including CRS and ICANS incidence and severity
Follow-up
Participants are monitored for safety and effectiveness after treatment, including long-term safety and RFS
What Are the Treatments Tested in This Trial?
Interventions
- CD22 CAR-transduced T cells
Trial Overview
The study tests if CD22 CAR T-cells can extend remission in ALL patients post-CD19 CAR therapy. It involves leukapheresis to collect T cells, lab modification of these cells, drug preparation, then infusion of the modified T cells back into the patient.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Lymphodepleting chemotherapy followed by CD22 CAR T-cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
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