Phase I Clinical Trial on the Use of Fresh, Allogeneic, Second-generation CD19-CAR T Cells for Treatment of Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
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).
• Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following:
‣ Relapse after alloHSCT OR
⁃ Relapsed/refractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19/CD22-directed monoclonal antibody and availability of a fully matched related donor.
• CD19+ count ≥ 50 cells/mcl and/or Minimal Residual Disease (MRD) ≥ 10\^-4.
• Voluntary informed consent. For subjects \< 18-years old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
• Clinical performance status: patients \> 16 years of age: Karnofsky greater than or equal to 60%; patients ≤ 16 years of age: Lansky score than or equal to 60%.
• Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the lymphodepletion regimen.
• Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.