OncoMatch/Clinical Trials/NCT05442515
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
Is NCT05442515 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including CD19/CD22-CAR-transduced T cells and cyclophosphamide for b-nhl.
Treatment: CD19/CD22-CAR-transduced T cells · cyclophosphamide · fludarabine — 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....
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 expression (>15% by ihc or >80% by flow cytometry (cohorts a1b, b1b, c2b); any positivity (cohorts d1b, 2 b-all))
Required: CD22 expression (positivity must be confirmed)
Demographics
Prior therapy
Must have received: systemic chemotherapy
Must have received: tyrosine kinase inhibitor — philadelphia chromosome + all
Lab requirements
Blood counts
leukocytes >= 750/mcl; platelets >= 50,000/mcl; not excluded for pancytopenia >= grade 3 if due to underlying bone marrow involvement by leukemia
Kidney function
creatinine <= age-based maximum or measured creatinine clearance >=60 ml/min/1.73 m^2
Liver function
total bilirubin <=2 x uln (except gilbert's disease >3x uln); ast(sgot)/alt(sgpt) <=10 x institutional uln
Cardiac function
left ventricular ejection fraction >= 45% or fractional shortening >=28%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05442515 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic chemotherapy and tyrosine kinase inhibitor.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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