2022-08-08
2024-12
2024-12
30
NCT05472857
Suzhou Immunofoco Biotechnology Co., Ltd
Suzhou Immunofoco Biotechnology Co., Ltd
INTERVENTIONAL
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression
Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (IMC002). Following manufacture of the drug product, subjects will receive preconditioning prior to IMC002 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
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 |
---|---|---|
2022-07-20 | N/A | 2024-03-04 |
2022-07-21 | N/A | 2024-03-06 |
2022-07-25 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: anti-claudin18.2 chimeric antigen receptor T-cell therapy anti-claudin18.2 chimeric antigen receptor T-cell therapy,infusion | BIOLOGICAL: Claudin 18.2 CAR-T
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Incidence of Treatment Related adverse events (AEs) | Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) | day1 - month12 |
Identification of Maximum Tolerated Dose (MTD) | Incidence of dose-limiting toxicities (DLTs) | day1 - day28 |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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. | day1 - month12 |
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. | day1 - month12 |
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. | day1 - month12 |
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. | day1 - month12 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Zhengmao Lu, MD Phone Number: +86 21 50907211 Email: [email protected] |
Study Contact Backup Name: Ai Guoqiang, MD Phone Number: 86-18482022722 Email: [email protected] |
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:
This is where you will find people and organizations involved with this study.
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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