A Clinical Study Of CHT102 In MSLN-Positive Advanced Pancreatic Cancer

Study Overview

A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer

Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.

Advanced Pancreatic Cancers

DRUG: CHT102

CHT102SIIT-02

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 2024-12-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-07
First Submitted that Met QC Criteria 2024-12-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-10
First Posted (ACTUAL) 2025-01-06	Results First Posted N/A	Last Verified 2024-11

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CHT102 infusion CHT102 will be dosing by arterial infusion.	DRUG: CHT102 CHT 102 : MSLN UCAR-T.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CHT102 infusion

CHT102 will be dosing by arterial infusion.

DRUG: CHT102

CHT 102 : MSLN UCAR-T.

Primary Outcome Measures	Measure Description	Time Frame
Safety and Tolerability	Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR)	The total response rate after 90 days of treatment with study drug.	At 4 weeks, and overall
Disease control rate (DCR)	The disease control rate after 90 days of treatment with study drug.	At 4 weeks, and overall
Progress-free survival(PFS)	PFS will be assessed from the first CHT102 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)	2 years
Overall survival (OS )	OS will be assessed from the first CHT102 infusion to death from any cause (Assessed based on RECIST criteria)	3 years
pharmacokinetics (PK)	Concentration levels of MSLN+ CAR-T cells	6 months
PD	Concentration levels of MSLN U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, etal	6 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: Jihui Hao, Ph.D

Phone Number: +86-02223340123

Email: haojihui@tjmuch.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.

Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.

Investigators

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

Learn

Resources

PatientS

Caregivers

Clinical Trial Record