An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer
This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Up to 3 times CT041 autologous CAR T-cell injection infusion
Physician's choice of any BSC listed above
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Phase Ib: Incidence of Treatment Related adverse events (AEs)
Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).
Time frame: Up to 18 months
Phase Ib: Identification of Maximum Tolerated Dose (MTD)
Incidence of dose-limiting toxicities (DLTs)
Time frame: day1-day28
Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: Up to 24 months
Phase Ib: Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: Up to 18 months
Phase Ib: Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: Up to 18 months
Phase Ib:Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of CT041 to the date of death due to any cause.
Time frame: Up to 18 months
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Peking University Shenzhen Hospital
Shenzhen, Guangzhou, China
Harbin medical university Affiliated Cancer Hospital
Harbin, Heilongjia, China
Henan Tumor Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
...and 14 more locations
Phase Ib:Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame: Up to 18 months
Phase Ib:Disease control rate (DCR), as assessed by Investigators
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time frame: Up to 18 months
Phase II: Overall survival (OS) of CT041 autologous CAR T-cell injection versus Physician's Choice
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to 24 months
Progression-free survival (PFS), as assessed by Investigators, of CT041 autologous CAR T-cell injection versus Physician's Choice
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.infusion
Time frame: Up to 24 months
Phase II:Objective Response Rate (ORR), as assessed by IRC and by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: Up to 24 months
Phase II: Duration of response (DOR), as assessed by IRC and by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame: Up to 24 months
Phase II: Disease control rate (DCR), as assessed by IRC and by Investigators
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time frame: Up to 24 months