Study To Evaluate The Efficacy, Safety And Pharmacokinetics Of CT041 Autologous CAR T-cell Injection

Study Overview

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

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.

Gastric Adenocarcinoma
Pancreatic Cancer
Gastroesophageal Junction Adenocarcinoma

DRUG: CT041 autologous CAR T-cell injection
DRUG: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

CT041-ST-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-09-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-05
First Submitted that Met QC Criteria 2020-10-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-06
First Posted (ACTUAL) 2020-10-09	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CT041 autologous CAR T-cell injection Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety	DRUG: CT041 autologous CAR T-cell injection Up to 3 times CT041 autologous CAR T-cell injection infusion
ACTIVE_COMPARATOR: Physician's Choice Participants will receive physician's choice of treatment in Phase II	DRUG: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） Physician's choice of any BSC listed above

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CT041 autologous CAR T-cell injection

Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety

DRUG: CT041 autologous CAR T-cell injection

Up to 3 times CT041 autologous CAR T-cell injection infusion

ACTIVE_COMPARATOR: Physician's Choice

Participants will receive physician's choice of treatment in Phase II

DRUG: Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody）

Physician's choice of any BSC listed above

Primary Outcome Measures	Measure Description	Time Frame
Phase Ib: Incidence of Treatment Related adverse events (AEs)	Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).	Up to 18 months
Phase Ib: Identification of Maximum Tolerated Dose (MTD)	Incidence of dose-limiting toxicities (DLTs)	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.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
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.	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.	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.	Up to 18 months
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.	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.	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.	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	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.	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.	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.	Up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lifeng Zhang, MD

Phone Number: 86-21-64501828

Email: lifengzhang@carsgen.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Peking University Cancer Hospital & Institute
Fudan University

Investigators

PRINCIPAL_INVESTIGATOR: Lin Shen, Professor, Peking University Cancer Hospital & Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record