Clinical Trial to Evaluate the Safety and Efficacy of IM92 CAR-T Cells Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma

NCT ID: NCT05275062

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-05-01

Brief Summary

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.

Conditions

Advanced Solid Tumors; Gastric Cancer; Esophagogastric Junction Cancer; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IM92 CAR-T cells

Group Type: EXPERIMENTAL

IM92 CAR-T cells

Intervention Type: DRUG

2.5×10\^8 CAR-T cells

Interventions

IM92 CAR-T cells

2.5×10\^8 CAR-T cells

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 75 years, either sex;
• Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed second-line treatment at least; or patients with pathologically diagnosed advanced pancreatic cancer who have failed first-line treatment at least;
• Tumor tissue samples were positive for CLDN18.2 IHC staining(≥+，≥10%);
• Estimated life expectancy >12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedure;
• Volunteer to participate in this trial and sign on the informed consent.

Exclusion Criteria

• Patients have brain metastasis；
• Patients with a history of organ transplantation or awaiting organ transplantation;
• The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; other tolerable events determined by investigator;
• There is a large amount of serous effusion that cannot be controlled by treatment (such as pleural effusion, peritoneal effusion and pericardial effusion);
• History of autoimmune disease (eg Crohn's disease, rheumatoid arthritis, systemic lupus) within the last 2 years;
• Presence of acute or chronic graft-versus-host disease (GVHD);
• Use prohibited drugs or treatments within a specified period of time before cell collection；
• History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
• Chronic or active infections requiring systemic treatment, and a history of symptomatic viral infection that has not been completely cured；
• Live vaccine received within 6 weeks before the start of screening;
• Cardiac dysfunction includes: long QTc syndrome or QTc interval > 480 MS; Complete left bundle branch block, grade II / III atrioventricular block; Serious and uncontrolled arrhythmias requiring drug treatment; A history of chronic congestive heart failure with NYHA ≥ 3, and the cardiac ejection fraction was less than 50% within 6 months before screening; Cardiac valvular disease with CTC AE ≥ 3; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, history of severe pericardial disease or other clinically significant heart diseases within 6 months before screening;
• Patients requiring anticoagulant therapy;
• Patients requiring continuous anti-platelet therapy;
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment;
• A history of other malignancies with a higher risk of recurrence was assessed by the investigator;
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and bacterial pharyngitis are permitted if the investigator evaluates that it can be controlled by treatment, they can be included in the group;
• Patients at high risk of hemorrhage or perforation;
• Patients were enrolled in another clinical study at the same time, unless it was an observational (non intervention) clinical study;
• In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianming Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA GENERAL HOSPITAL

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Wu, MD

Role: CONTACT

wufei@immunochina.com

+8615801390058

Facility Contacts

Jianming Xu, M.D.

Role: primary

Jianmingxu2014@163.com

+8613910866712

Other Identifiers

YMCART9201

Identifier Type: -

Identifier Source: org_study_id