An Open-label, Single-arm, Multicenter, Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of CT041 Autologous CAR T Cell Injection After Adjuvant Chemotherapy in Subjects With Pancreatic Cancer

CARsgen Therapeutics Co., Ltd.8 sites in 1 country20 target enrollmentJuly 11, 2023

ConditionsPancreatic Cancer

InterventionsCT041 autologous CAR T-cell injection

Overview

Phase: Phase 1
Intervention: CT041 autologous CAR T-cell injection
Conditions: Pancreatic Cancer
Sponsor: CARsgen Therapeutics Co., Ltd.
Enrollment: 20
Locations: 8
Primary Endpoint: Disease free survival (DFS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Detailed Description

This study is an open, multicenter, Phase Ib 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 pancreatic cancer who has undergone adjuvant chemotherapy. The aim of this study is to evaluate the efficacy, safety of CT041 treatment.

Registry

clinicaltrials.gov

Start Date

July 11, 2023

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CARsgen Therapeutics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures;
•Aged 18 to 79 years;
•Histologically confirmed pancreatic ductal adenocarcinoma;
•Macroscopic complete tumor removal (R0 or R1 resection);
•Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
•Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
•Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;
•Abnormal CA19-9 level;
•With sufficient venous access for leukapheresis collection;
•ECOG performance status score 0-1;

Exclusion Criteria

•Prior neoadjuvant therapy for pancreatic cancer;
•Subjects with borderline resectable pancreatic cancer;
•Present or past history of metastatic or locally recurrent pancreatic cancer;
•Evidence of malignant ascites;
•Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
•Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;
•Pregnant or lactating women;
•Positive serology for HIV, Treponema pallidum or HCV;
•Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
•Clinically significant thyroid dysfunction;

Arms & Interventions

anti-claudin18.2 chimeric antigen receptor T-cell therapy

Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041

Intervention: CT041 autologous CAR T-cell injection

Outcomes

Primary Outcomes

Disease free survival (DFS)

Time Frame: Up to 18 months

The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.

Secondary Outcomes

Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI).(Up to 18 months)
1 year DFS rate(Up to 18 months)
Overall Survival (OS)(Up to 18 months)
The phamacokinetics in subjects receiving CT041 infusion in this study(Up to 18 months)
Metastasis free Survival (MFS)(Up to 18 months)
The immunogenicity in subjects receiving CT041 infusion in this study(Up to 18 months)