NCT05287165
Unknown
Early Phase 1
Clinical Trial to Evaluate the Safety and Efficacy of IM96 CAR-T Cells Therapy in Patients With Advanced Digestive System Neoplasms
Beijing Immunochina Medical Science & Technology Co., Ltd.1 site in 1 country19 target enrollmentStarted: March 10, 2022Last updated:
ConditionsAdvanced Solid TumorsDigestive System NeoplasmsPancreatic Cancer ResectableColorectal (Colon or Rectal) Cancer
InterventionsIM96 CAR-T cells
DrugsIM96 CAR-T cells
Overview
- Phase
- Early Phase 1
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment Related adverse events (AEs)
Overview
Brief Summary
This is a open-label, single center to determine the efficacy and safety of IM96 CAR-T cells in Patients With Advanced Digestive System Neoplasms
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- 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 gastrointestinal cancer:Patients with metastatic colorectal cancer who have failed or cannot tolerate second-line or above standard treatment;Patients with unresectable locally advanced or metastatic pancreatic cancer who have failed or cannot tolerate first-line or above standard treatment; Patients with unresectable locally advanced or metastatic other gastrointestinal cancer (gastric cancer, esophageal cancer, small intestinal cancer, etc.) who have failed or cannot tolerate standard treatment, or have no standard treatment regimen;
- •At least one measurable lesion meeting RECIST 1.1 criteria;
- •Tumor tissue samples were positive for GUCY2C IHC staining;
- •Estimated life expectancy \>3 months;
- •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;
- •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
IM96 CAR-T cells
Experimental
Intervention: IM96 CAR-T cells (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment Related adverse events (AEs)
Time Frame: Up to 28 days after CAR-T cell infusion
Incidence of treatment related AE.
Secondary Outcomes
- Objective response rate (ORR)(Up to 24 weeks after CAR-T cell infusion)
- Duration of Response (DOR)(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)
- Progression-free survival (PFS)(Up to 24 weeks after CAR-T cell infusion)
Investigators
Study Sites (1)
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