OncoMatch/Clinical Trials/NCT05442515
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
Is NCT05442515 recruiting? Yes, currently enrolling (May 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
Cancer type
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Biomarker criteria
Required: CD19 overexpression (>15% by IHC or >80% by flow cytometry)
CD19 must be detected on >15% of the malignant cells by immunohistochemistry or > 80% by flow cytometry.
Required: CD22 positivity (confirmed)
CD22 positivity must be confirmed.
Prior therapy
Must have received: chemotherapy
relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment
Must have received: tyrosine kinase inhibitor
Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor
Must have received: CAR-T cell therapy (CD19 CAR T-cell construct) — commercially available
unable to access (in a timely manner), ineligible for, or have relapsed/failed after or not responded to a commercially available CD19 CAR T-cell construct
Cannot have received: systemic chemotherapy, anti-neoplastic agents, antibody-based therapies
Exception: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects
Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies; Washout*: >=2 weeks
Cannot have received: radiation therapy
Exception: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable/evaluable disease outside the radiation window
Therapy: Radiation; Washout*: >=3 weeks
Cannot have received: allogeneic stem cell transplant
Therapy: Allogeneic Stem Cell Transplant; Washout*: >= 100 days since SCT; >= 30 days since completion of immunosuppression; >= 6 weeks since donor lymphocyte infusion (DLI)
Cannot have received: CAR-T cell therapy or other adoptive cell therapy
Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy; Washout*: > 30 days post infusion
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 <= the maximum for age listed OR measured creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above the max listed below per age
Liver function
total bilirubin <=2 X ULN (except Gilbert's disease >3x ULN); AST(SGOT)/ALT(SGPT) <=10 X ULN
Cardiac function
Left ventricular ejection fraction >= 45% or fractional shortening >=28%
Participants must have adequate organ and marrow function as defined below: leukocytes >= 750/mcL*; platelets >= 50,000/mcL*; total bilirubin <=2 X ULN (except in the case of participants with documented Gilbert's disease > 3x ULN); AST(SGOT)/ALT(SGPT) <=10 X institutional upper limit of normal; creatinine <= the maximum for age listed in the table below OR measured creatinine clearance >=60 mL/min/1.73 m^2 for participants with creatinine levels above the max listed below per age. 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
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