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

NCT05275062 | Unknown Early Phase 1

• 1 other identifier: YMCART9201
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  Incidence of treatment related AEs

  Up to 28 days after CAR-T cell infusion

Secondary Outcomes (7)

• Objective response rate (ORR)

  Up to 24 weeks after CAR-T cell infusion

• Disease Control Rate（DCR）

  Up to 24 weeks after CAR-T cell infusion

• Progression-free survival (PFS)

  Up to 24 weeks after CAR-T cell infusion

• Overall survival (OS)

  Up to 24 weeks after CAR-T cell infusion

• Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)

  Up to 24 weeks after CAR-T cell infusion

Study Arms (1)

IM92 CAR-T cells

EXPERIMENTAL

Drug: IM92 CAR-T cells

Interventions

IM92 CAR-T cells DRUG

2.5×10\^8 CAR-T cells

IM92 CAR-T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Chinese PLA GENERAL HOSPITAL

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jianming Xu, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058; wufei@immunochina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: February 15, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

CN (1)