A phase I/IIa safety, dose finding and feasibility trial of CD30/CEA CART in patients with liver metastases from CEA positive colorectal adenocarcinoma

Conditions

Colorectal Adenocarcinoma

Brief summary

Incidence and severity of adverse events (AEs) and adverse events of special interest (AESIs) grouped by MedDRA system organ class and preferred terms and according to CTCAE version 6.0*, Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period, Percent (%) of subjects who received the planned dose of CD30/CEA CART

Detailed description

Key secondary efficacy endpoint: Objective response rate (ORR) defined as the proportion of patients in whom a CR or PR per RECIST v1.1 is observed as best overall response, Disease control rate (DCR) defined as the proportion of patients in whom CR, PR, or stable disease (SD; lasting 6 or more weeks) is observed as best overall response, Duration of response (DoR) defined as the time from the first objective response (CR or PR per RECIST v1.1) to first occurrence of objective progressive disease (PD) per RECIST v1.1/recurrence or death from any cause, whichever occurs first, Progression-free survival (PFS) based on RECIST v1.1, Time to progression (TTP), Overall survival (OS), Quantification of CD30/CEA CART in peripheral blood

Related papers

No related papers found yet.

Interventions

DRUGCD30/CEA CART

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (AEs) and adverse events of special interest (AESIs) grouped by MedDRA system organ class and preferred terms and according to CTCAE version 6.0*, Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period, Percent (%) of subjects who received the planned dose of CD30/CEA CART	—

Secondary

Measure	Time frame
Key secondary efficacy endpoint: Objective response rate (ORR) defined as the proportion of patients in whom a CR or PR per RECIST v1.1 is observed as best overall response, Disease control rate (DCR) defined as the proportion of patients in whom CR, PR, or stable disease (SD; lasting 6 or more weeks) is observed as best overall response, Duration of response (DoR) defined as the time from the first objective response (CR or PR per RECIST v1.1) to first occurrence of objective progressive disease (PD) per RECIST v1.1/recurrence or death from any cause, whichever occurs first, Progression-free survival (PFS) based on RECIST v1.1, Time to progression (TTP), Overall survival (OS), Quantification of CD30/CEA CART in peripheral blood	—

Measure

Time frame

Key secondary efficacy endpoint: Objective response rate (ORR) defined as the proportion of patients in whom a CR or PR per RECIST v1.1 is observed as best overall response, Disease control rate (DCR) defined as the proportion of patients in whom CR, PR, or stable disease (SD; lasting 6 or more weeks) is observed as best overall response, Duration of response (DoR) defined as the time from the first objective response (CR or PR per RECIST v1.1) to first occurrence of objective progressive disease (PD) per RECIST v1.1/recurrence or death from any cause, whichever occurs first, Progression-free survival (PFS) based on RECIST v1.1, Time to progression (TTP), Overall survival (OS), Quantification of CD30/CEA CART in peripheral blood

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Outcome results

None listed