Actively Recruiting
Phase 1/2 Dose Escalation Study of CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-05-28
130
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new CAR T-cell therapy designed to treat children and young adults aged 3 to 39 with recurrent or refractory B-cell acute lymphoblastic leukemia (ALL) or related B-cell lymphomas. This trial addresses the challenge of cancer returning after standard treatments, which significantly lowers survival rates. The study aims to test a novel dual-targeting CAR T-cell treatment that focuses on both CD19 and CD22 proteins found on most ALL cells, aiming to improve treatment durability and effectiveness. Participants receive genetically modified T cells created from their own blood, which are engineered to target both CD19 and CD22 proteins simultaneously. Before treatment, participants undergo chemotherapy as a preparative step and receive one of two lymphodepleting regimens based on their condition. After T cells are modified in a lab, these CAR T cells are infused back into the patient. The study includes a dose-escalation design with multiple cohorts based on disease burden and antigen expression, and participants are monitored for safety and treatment effects. During the study, participants undergo extensive screening including physical exams, lab tests, lung and heart function assessments, imaging scans, bone marrow biopsies, and lumbar punctures. After receiving the CAR T-cell infusion, participants visit the clinic twice weekly for 28 days for monitoring, with follow-up continuing for up to 15 years. Researchers evaluate safety within 30 days post-infusion and monitor efficacy and other outcomes such as response, survival, and CAR T-cell persistence for up to two years. Long-term safety and biological effects are also assessed throughout the study.
CONDITIONS
Brief Title
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 3 to 39 years
- Diagnosis of B cell acute lymphoblastic leukemia, CML with ALL transformation, or high-grade B-cell lymphoma
- Relapsed or refractory disease after at least one standard chemotherapy and one salvage treatment
- Ineligible for, refused, or recurred after stem cell transplant
- Unable to access or relapsed after commercially available CD19 CAR T-cell therapy
- Evidence of minimal residual disease or PET-avid lymphoma at enrollment
- Adequate organ and marrow function as defined in the protocol
- Acceptable cardiac and pulmonary function
- Willingness to use effective birth control during and after treatment
- Willingness to discontinue breastfeeding during treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- CNS3 disease or progressing neurologic signs of CNS disease
- Active CNS lymphoma detected by imaging
- Hyperleukocytosis (≥ 50,000 blasts/microL)
- Positive pregnancy test
- Insufficient time since prior therapies (chemotherapy, radiation, stem cell transplant, CAR T-cell therapy) per washout periods
- Active HIV or hepatitis B or C infection
- Active second malignancy except certain treated cancers in remission
- History of severe allergic reactions to similar agents
- Uncontrolled illness or social situations limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 5 days
Participants receive cyclophosphamide and fludarabine in one of two lymphodepleting regimens prior to CAR T-cell infusion.
Daily visits for 3 to 5 days (in-person)
Duration - 1 day
Participants receive a single infusion of CD19/CD22-CAR-transduced T cells after the preparative regimen.
1 infusion visit (in-person)
Duration - Up to 2 years post infusion
Participants are monitored for safety, efficacy, CAR T-cell expansion and persistence, and adverse events after treatment.
Monthly visits until 3 months post infusion, then visits at 6 months and every 6 months thereafter (in-person)
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
N
Nirali N Shah, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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