A Phase I Dose Finding Study of MB-CART2219.1
Trial Parameters
Brief Summary
A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies
Eligibility Criteria
Inclusion Criteria: 1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF. 3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures. 4. Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials. 5. CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available. 6. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective con