OncoMatch/Clinical Trials/NCT06080191
Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
Is NCT06080191 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD19-CAR_Lenti_ALLO for b-cell acute lymphoblastic leukemia.
Treatment: CD19-CAR_Lenti_ALLO — This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (CD19+ count ≥ 50 cells/mcl)
Patients with a diagnosis of CD19 expressing B ALL relapse; CD19+ count ≥ 50 cells/mcl
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplant — relapse after alloHSCT
Relapse after alloHSCT
Must have received: CD19/CD22-directed monoclonal antibody — relapsed/refractory disease, failure of frontline therapy and at least 2 rescue strategies
Relapsed/refractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19/CD22-directed monoclonal antibody
Cannot have received: systemic steroids
Exception: physiologic replacement doses only, no increase for at least 2 weeks to starting apheresis; recent or recurrent use of inhaled/topical/non-absorbable steroids is not exclusionary
systemic steroids (at a dose of ≥ 2 mg/kg prednisone) in the 2 weeks before infusion of CD19-CAR_Lenti_ALLO cells
Cannot have received: systemic chemotherapy
Exception: intrathecal chemotherapy allowed if complete recovery from acute toxic effects
systemic chemotherapy in the 2 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells
Cannot have received: anti-thymocyte globulin (Alemtuzumab)
anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells
Cannot have received: immunosuppressive agents
immuno-suppressive agents in the 2 weeks preceding infusion of CD19-CAR_Lenti_ALLO cells
Cannot have received: radiation therapy
radiation therapy must have been completed at least 2 weeks before infusion of CD19-CAR_Lenti_ALLO cells
Cannot have received: anti-neoplastic investigational agents
other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion of CD19-CAR_Lenti_ALLO cells
Lab requirements
Kidney function
serum creatinine ≤ 3x ULN for age
Liver function
total bilirubin ≤ 4x ULN; transaminase (ALT and AST) ≤ 6x ULN
Cardiac function
left ventricular ejection fraction ≥ 45% by ECHO
Hepatic function: inadequate liver function defined as total bilirubin > 4x ULN or transaminase (ALT and AST) > 6x ULN. Renal function: serum creatinine >3x ULN for age. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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