This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Number of subjects with dose limiting toxicities (DLTs)
Time frame: 28 days after TmCD19-IL18 CART T cell infusion
Determination of maximum tolerated dose (MTD)
Time frame: 28 days after TmCD19-IL18 CART T cell infusion
Incidence of Adverse Events as assessed by CTCAE v5.0
Time frame: Up to 15 years
Percentage of manufacturing products that meet release criteria
Time frame: 1 month
Overall response rate (ORR)
Time frame: 4 months
Best overall response (BOR)
Time frame: 12 months
Duration of response (DOR)
Time frame: 15 years
Overall Survival (OS)
Time frame: 15 years
Progression Free Survival (PFS)
Time frame: 15 years
Characterize low level disease and B cell assessment in response to TmCD19-IL18 CAR T cells
Polychromatic flow cytometry-based assessment of lymphoma and B cells
Time frame: 15 years
Characterize low level disease and B cell assessment in response to TmCD19-IL18 CAR T cells
Presence or absence of malignant B cells by Next-Generation Immunoglobulin Heavy Chain Sequencing (NGIS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 15 years