DLT) during cycle 1. Six dose levels were planned. The CRM design allowed more rapid accrual: once the maximum 3 patients were on the dose level under evaluation, further patients received the dose level below, with all data contributing to dose decisions. Ph 2 used a single stage A'Hern design to assess best ORR during the first 8 cycles (assessed using the Revised Response Criteria for Malignant Lymphoma) of the combination in all participants (pts) treated at the MTD. ROMI was given IV on days 1, 8 and 15 of a 28d cycle; CAR IV on days 1, 2, 8, 9, 15 and 16. HR23B expression was performed on formalin fixed paraffin embedded tissue.Results: 33 pts enrolled to Ph 1 with 27 evaluable for MTD assessment. 34 pts were treated at the MTD and evaluable for Ph 2. Median age 62y (22-82y); 69% male; median prior treatment lines 2 performance status 0 (44%), 1 (44%) or 2 (10%) (1 unknown); 53% refractory to last treatment. 51% had PTCL Not Otherwise Specified; 40% angioimmunoblastic T-cell lymphoma. 7 DLTs were seen in 6 patients during phase 1. The MTD was defined as ROMI 10 mg/m 2 with CAR 20mg/m 2 for 2 doses then 40mg/m 2 , giving an estimated posterior DLT probability of 0.216 with a 90% credible interval (0.106, 0.352). The ORR at the MTD was 32% (95% confidence interval 19-49%): 15% complete response, 18% partial response, 18% stable disease. Grade 3/4 adverse events in ≥ 10% pts were anaemia (17%); neutropenia (35%); thrombocytopenia (42%). Median PFS was 4.0 months (median follow up 19 months); 4 participants remain on treatment. HR23B expression was not associated with response with 27% (3 of 11) HR23B positive pts responding.
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