Actively Recruiting
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed/refractory B cell acute lymphoblastic leukemia (ALL) confirmed by pathology
- History showing CD19 and CD22 expression on cancer cells
- Age 3 to 65 years
- Received FDA-approved CD19 CAR T-cell therapy 2 to 7 months before leukapheresis or preparative treatment
- In MRD-negative remission confirmed by flow cytometry at screening
- Not eligible for or unwilling to have allogeneic stem cell transplant
- Karnofsky score 50% or higher (if 16 years or older) or Lansky score 50% or higher (if under 16 years)
- No ongoing cytokine release syndrome or neurotoxicity symptoms from prior CAR T therapy
- Adequate organ function including bilirubin, liver enzymes, kidney function, heart function, and lung oxygen levels
- Women of childbearing potential must agree to use highly effective birth control during the study and for 12 months after last chemotherapy dose
- Men able to father children must use effective contraception during the study and for 7 months after last dose
- Willing to stop nursing from treatment start through 6 months after last dose
- Enrolled in a follow-up study for gene therapy adverse events
- Able to understand and sign informed consent
You will not qualify if you...
- Any central nervous system involvement or signs of disease outside the bone marrow
- Active graft versus host disease after stem cell transplant
- Disease recurrence requiring therapy after CD19 CAR T-cell treatment (except maintenance therapy with a 1-week washout)
- Use of any investigational drug within 1 week before leukapheresis or preparative treatment
- Pregnancy confirmed by test at screening
- HIV infection
- Hepatitis B or C infection
- History of severe allergic reaction to similar drugs or compounds
- Uncontrolled illness or social situations that prevent study compliance or pose risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Pediatric Leukemia, Lymphoma Transpl
CONTACT
S
Sara K Silbert, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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