Clinical Trial to Evaluate the Safety and Efficacy of IM96 CAR-T Cells Therapy in Patients With Advanced Digestive System Neoplasms

NCT05287165 | Unknown Early Phase 1

• 1 other identifier: YMCART9601
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumors; Digestive System Neoplasms; Pancreatic Cancer Resectable; Colorectal (Colon or Rectal) Cancer

Keywords

Digestive System Neoplasms; Pancreatic Cancer Resectable; Colorectal (Colon or Rectal) Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Related adverse events (AEs)

  Incidence of treatment related AE.

  Up to 28 days after CAR-T cell infusion

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

IM96 CAR-T cells

EXPERIMENTAL

Drug: IM96 CAR-T cells

Interventions

IM96 CAR-T cells DRUG

treatment with anti-GUCY2C chimeric antigen receptor T-cell infusion

IM96 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 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.

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 malignancy other than non melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast), unless it has been disease-free for at least 3 years;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Lin Shen, Ph.D

  Peking University Cancer Hospital & Institute

  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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: March 10, 2022
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

CN (1)