Comparison of CD19/CD3-bispecific TCE and autologous CD19 CAR-T cells
| Feature . | CD19/CD3-bispecific TCE . | Autologous CD19 CAR-T cell therapy . |
|---|---|---|
| Manufacturing | • Standard antibody manufacturing • Off-the-shelf availability | • Individualized CAR-T cell production; delayed treatment • High cost and complexity |
| Mode of action | • Can potentially engage all T cells in a patient for redirected target cell lysis • Potential to eliminate cells expressing very low levels of CD19 | • Redirected target cell lysis relies on limited number of genetically engineered T cells |
| PK/pharmacodynamics (PD) | • Antibody construct with well-defined PK/PD properties | • “Living drug” with difficult-to-predict PK/PD |
| Administration | • IV or SC administration with potential for self-administration • Ability to re-treat if required | • Onetime treatment • IV route only |
| Safety | • CRS and ICANS • SC administration and step-up dosing have potential to limit CRS and ICANS to grade 1 or 2 | • Risk for grade 3 and higher CRS and ICANS • Adverse events from lymphodepletion • Risk of secondary T cell malignancies |
| Experience with modality | • Eight FDA-approved TCEs (five targets) | • Six FDA-approved CAR-T cell products (two targets) |
| Feature . | CD19/CD3-bispecific TCE . | Autologous CD19 CAR-T cell therapy . |
|---|---|---|
| Manufacturing | • Standard antibody manufacturing • Off-the-shelf availability | • Individualized CAR-T cell production; delayed treatment • High cost and complexity |
| Mode of action | • Can potentially engage all T cells in a patient for redirected target cell lysis • Potential to eliminate cells expressing very low levels of CD19 | • Redirected target cell lysis relies on limited number of genetically engineered T cells |
| PK/pharmacodynamics (PD) | • Antibody construct with well-defined PK/PD properties | • “Living drug” with difficult-to-predict PK/PD |
| Administration | • IV or SC administration with potential for self-administration • Ability to re-treat if required | • Onetime treatment • IV route only |
| Safety | • CRS and ICANS • SC administration and step-up dosing have potential to limit CRS and ICANS to grade 1 or 2 | • Risk for grade 3 and higher CRS and ICANS • Adverse events from lymphodepletion • Risk of secondary T cell malignancies |
| Experience with modality | • Eight FDA-approved TCEs (five targets) | • Six FDA-approved CAR-T cell products (two targets) |