NCT05275062
Unknown
Early Phase 1
Clinical Trial to Evaluate the Safety and Efficacy of IM92 CAR-T Cells Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma
Beijing Immunochina Medical Science & Technology Co., Ltd.1 site in 1 country6 target enrollmentStarted: February 15, 2022Last updated:
InterventionsIM92 CAR-T cells
DrugsIM92 CAR-T cells
Overview
- Phase
- Early Phase 1
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events (AEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
IM92 CAR-T cells
Experimental
Intervention: IM92 CAR-T cells (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events (AEs)
Time Frame: Up to 28 days after CAR-T cell infusion
Incidence of treatment related AEs
Secondary Outcomes
- Disease Control Rate（DCR）(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)
- 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)
- Objective response rate (ORR)(Up to 24 weeks after CAR-T cell infusion)
- Progression-free survival (PFS)(Up to 24 weeks after CAR-T cell infusion)
Investigators
Study Sites (1)
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