OncoMatch/Clinical Trials/NCT06408194
Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
Is NCT06408194 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CD22CART infusion and Tisagenlecleucel for leukemia.
Treatment: CD22CART infusion · Tisagenlecleucel — The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (any level of expression)
Required: CD22 expression (any level of expression)
Prior therapy
Must have received: CAR-T cell therapy (tisagenlecleucel) — refractory disease or in second or later relapse
Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse)
Lab requirements
Blood counts
ANC ≥ 750/uL; Platelet count ≥ 50,000/uL; ALC > 150/uL; cytopenias not due to underlying disease do not exclude
Kidney function
Creatinine within ULN for age or Creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 mg/dl, except in Participants with Gilbert's syndrome. ALT or AST ≤ 10 x ULN (except in Participants with liver involvement by leukemia)
Cardiac function
Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by Echocardiogram
Normal Organ and Marrow Function: ANC ≥ 750/uL; Platelet count ≥ 50,000/uL; ALC > 150/uL; Baseline oxygen saturation > 92% on room air; Creatinine within ULN for age or Creatinine clearance ≥ 60 mL/min; Total bilirubin ≤ 1.5 mg/dl, except in Participants with Gilbert's syndrome. ALT or AST ≤ 10 x ULN (except in Participants with liver involvement by leukemia); Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by Echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
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