This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Subjects must have relapsed or refractory ALL, lymphoma or CLL treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
2. The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
Age 2 to 70 years.
Performance status: Adult Subjects: ECOG ≤ 2 for patients ≥ 16 years; Subjects < 16 years of age: lansky ≥ 50%
Autologous transplant within 6 weeks of planned CAR-T cell infusion;
History of allogeneic stem cell transplant 4 months prior CAR T cell infusion.
Use of immunosuppression therapy;
Presence of graft-versus-host disease Grade ≥ 2;
Nelson Hamerschlak
Lead sponsor
Hospital Israelita Albert Einstein
Sponsor institution
Miltenyi Biotec, Inc.
Collaborator