Clinical Data

In the core group at dose level 2 (DL2=100 million cells), the data showed a 3 month overall response rate (ORR) of 74% (14/19) and a 3 month complete response (CR) rate of 68% (13/19). Of patients that have reached 6 months of follow-up, 50% (7/14) were in CR. Across doses, 80% (16/20) of patients in core group with CR at 3 months stayed in CR at 6 months, and 92% (11/12) of patients in response at 6 months remained in response as of the data cutoff date.

In the core group, 1% (1/67) experienced severe cytokine release syndrome and 15% (10/67) experienced severe neurotoxicity. 58% (39/67) had no CRS or NT of any grade.

In the full group, 1% (1/91) experienced severe CRS and 12% (11/91) experienced severe NT. 60% (55/91) had no CRS or NT of any grade.

The most common treatment-emergent adverse events (TEAEs) other than CRS and NT that occurred at ≥25% in the full group included neutropenia (49%), anemia (38%), fatigue (37%), thrombocytopenia (29%), nausea (27%), and diarrhea (25%). The most common TEAEs were similar between core and full groups.