OncoMatch/Clinical Trials/NCT06080191
Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
Is NCT06080191 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT06080191 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic steroids, systemic chemotherapy, anti-thymocyte globulin disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 35 years or younger and at least 1 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.
Check if I qualifyRelated pages