Actively Recruiting
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-03-12
126
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Acute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses. Objective: To test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL. Eligibility: People aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy. Design: Participants will be screened. This will include: Physical exam Blood and urine tests Tests of their lung and heart function Imaging scans Bone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone. Lumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord. Participants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells. Participants will receive chemotherapy starting 4 or 5 days before the CAR treatment. Participants will be admitted to the hospital. Their own modified T cells will be returned to their body. Participants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....
CONDITIONS
Official Title
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed B cell acute lymphoblastic leukemia, CML with ALL transformation, or high-grade lymphoma.
- Participants must have relapsed or been refractory after at least one standard and one salvage chemotherapy regimen.
- Participants must be ineligible for or have failed allogeneic stem cell transplant.
- No evidence of graft-versus-host disease and off immunosuppressive agents for at least 30 days if prior transplant.
- Unable to access or have failed commercially available CD19 CAR T-cell therapy.
- Evidence of minimal residual disease or PET-avid lymphoma at enrollment.
- CD19 expression on >15% of malignant cells by immunohistochemistry or >80% by flow cytometry.
- Confirmed CD22 positivity.
- Age between 3 and 39 years at enrollment.
- Karnofsky or Lansky performance status ≥ 50%.
- Adequate organ and marrow function as specified, including leukocytes ≥ 750/mcL and platelets ≥ 50,000/mcL.
- Left ventricular ejection fraction ≥ 45% or fractional shortening ≥ 28%.
- Baseline oxygen saturation >92% on room air at rest.
- Willingness to practice effective birth control and discontinue breastfeeding as required.
- Ability to understand and sign informed consent and co-enroll in follow-up studies.
You will not qualify if you...
- CNS3 disease or active neurological signs of CNS disease.
- Radiologically active CNS lymphoma.
- Hyperleukocytosis with ≥ 50,000 blasts/microL.
- Positive pregnancy test.
- Failure to meet washout periods for prior systemic chemotherapy, radiation, stem cell transplant, or CAR T-cell therapy.
- Positive HIV, Hepatitis B surface antigen, or Hepatitis C antibodies indicating active infection.
- Active second malignancy except certain treated tumors in remission.
- History of severe allergic reaction to study agents or related compounds.
- Uncontrolled illness or social situations limiting compliance or posing risk per investigator judgment.
AI-Screening
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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
N
Nirali N Shah, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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