Safety and tolerability data:
Of the six patients dosed at the first two dose levels (30×106 and 100×106 cells per infusion):
- No dose limiting toxicity (DLT), Graft-versus Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) were observed in the first two dose cohorts.
- One cytokine release syndrome (CRS) Grade 1 (fever) requiring hospitalization occurred 10 days post CYAD-211 administration in patient 1 (dose level 1) who achieved a partial response (PR).
- One patient experienced an anemia adverse event (Grade 3) and neutropenia (Grade 4) possibly related to CYAD-211.
Of the five evaluable patients at the first two dose levels (30×106 and 100×106 cells per infusion):
- Two patients achieved a PR. Both patients were ‘triple-therapy exposed’ (previously treated with an immunomodulator (IMiD), a proteasome inhibitor and an anti-CD38 antibody).
- The three additional patients had stable disease (SD).
- CYAD-211 cells were detected by PCR-based methods in all six patients from dose cohorts 1 and 2.
- Cell engraftment was seen in all three patients at dose level 2 at a similar magnitude. In addition, preliminary data suggest that all patients in dose level 2 showed deep lymphodepletion. Across dose level 1, the depth of lymphodepletion appears to correlate with the degree of observed systemic CAR T engraftment.
- Enrollment in dose cohort 3 (300×106 cells per infusion) is ongoing.
- Additional clinical data from the dose escalation trial are expected during second half 2021.
- shRNA technology platform to be highlighted at upcoming virtual R&D Day in Q3 2021.