Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a open-label, single center to determine the efficacy and safety of IM92 CAR-T cells in Patients With advanced gastric/esophagogastric combination adenocarcinoma that has failed at least second-line therapy and advanced pancreatic cancer that has failed at least first-line therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM92 CAR-T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM92 CAR-T cells | Drug | 2.5×10^8 CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of treatment related AEs | Up to 28 days after CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1 | Up to 24 weeks after CAR-T cell infusion |
| Disease Control Rate(DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Wu, MD | Contact | +8615801390058 | wufei@immunochina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianming Xu, M.D. | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA GENERAL HOSPITAL | Recruiting | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
DCR,defined as the number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%). |
| Up to 24 weeks after CAR-T cell infusion |
| Progression-free survival (PFS) | PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to RECIST v1.1 | Up to 24 weeks after CAR-T cell infusion |
| Overall survival (OS) | OS , defined as the time from CAR-T cell infusion to death from any cause | Up to 24 weeks after CAR-T cell infusion |
| Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood) | The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR. | Up to 24 weeks after CAR-T cell infusion |
| Response rate of tumor markers (CEA, CA19-9) before and after CAR-T cells infusion | Up to 24 weeks after CAR-T cell infusion |
| Anti-therapeutic IM92 CAR-T cells antibody | Up to 24 weeks after IM92 CAR-T cell infusion |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided