All five patients showed tumor regression including two RECIST unconfirmed partial responses and two patients with stable disease through six months.
Translational data further demonstrated TRuC-T cell expansion and activation. A manageable toxicity profile was observed with only one patient exhibiting TC-210-related non-hematologic grade >2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity.
The primary objectives of the Phase 1 portion are to define the safety profile of TC-210 in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose (RP2D).
Secondary objectives include overall response rate (ORR) and disease control rate (DCR). Exploratory objectives include the assessment of expansion, tumor infiltration, and persistence of TC-210 T cells.
In the Phase 2 portion of the trial, approx. 50 patients are planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma.
The company will host a conference call and webcast today at 8:00 am E.T.
Previously: TCR² Therapeutics to announce interim data from its lead drug’s early-stage study (July 24)