Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers | NCT05779917

Studies
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

NCT05779917

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Status

Recruiting

Last Update Posted

Jun 25, 2024Actual

Enrollment

30Estimated

Phase

Phase 1

Conditions

Pancreas Cancer
CAR-T Cell Therapy
Mesothelin
Solid Tumor, Adult

Interventions

CAR-T cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2023Actual

Primary Completion Date

Mar 10, 2029Estimated

Completion Date

Mar 10, 2036Estimated

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Mar 10, 2023

First Posted Date

Mar 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2024

Last Update Posted Date

Jun 25, 2024Actual

Name	Class
Fapon Biotherapy Inc.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Detailed Description

Choose appropriate patients with advanced pancreatic cancer or other cancers, with written consent for this study;
Perform biopsy to determine the expression of Mesothelin of the tumors by western blotting or IHC;
Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T cells as needed, test the quality and killing activity of the CAR-T cells and then transfer them back the patients via systemic or local injections, and follow up closely to collect related results as required;
To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
Evaluate the clinical results as needed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
CAR-T cells	Biological	Transfer CAR-T cells into patients for anti-ancer therapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients with Dose Limiting Toxicity	A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the Mesothelin-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.	six months

Secondary Outcomes

Measure	Description	Time Frame
Percent of Patients with best response as either complete remission or partial remission.	Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.	six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Exclusion Criteria:

Had accepted gene therapy before;
Severe virus infection such as HBV, HCV, HIV, et al;
Known HIV positivity;
Active infectious disease related to bacteria, virus,fungi,et al;
Other severe diseases that the investigators consider not appropriate;
Pregnant or lactating women;
Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
Other conditions that the investigators consider not appropriate. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenfeng Zhang, MD, PhD	Contact	0086-020-39195965		zhangzhf@gzhmu.edu.cn
Bingjia He, MD	Contact	+862039195965		464677938@qq.com

Overall Officials

Name	Affiliation	Role
Zhenfeng Zhang, MD, PhD	Second Affiliated Hospital of Guangzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Guangzhou Medical University	Recruiting	Guangzhou	Guangdong	510260	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016219	Immunotherapy, Adoptive

Ancestor Terms

ID	Term
D019264	Adoptive Transfer
D007116	Immunization, Passive
D007114	Immunization
D007167	Immunotherapy

Browse Leaves

Not provided

Browse Branches

Not provided