CD276-targeted Chimeric Antigen Receptor T Cells in Treatment With Advanced Pancreatic Cancer

NCT05143151 | Unknown Phase 1

• 1 other identifier: HEM-ONCO-013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

CD276 (B7-H3) is a member of the B7 costimulatory molecule family. Its mRNA is widely expressed in tissues, but the protein expression is limited. It is expressed in resting fibroblasts, endothelial cells, osteoblasts, amniotic fluid stem cells and other non-immune cells, and The surface of induced antigen-presenting cells and NK cells. Many studies have revealed that B7-H3 is overexpressed in a variety of tumors, including melanoma, pancreatic cancer, breast cancer, prostate cancer, colorectal cancer and other tumors, and its expression level is closely related to the poor prognosis and clinical outcome of patients . Preclinical studies have confirmed that the expression of CD276 mRNA in pancreatic cancer tissues is significantly higher than that of normal adjacent groups.

Conditions

Advanced Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  up to 1 year

Secondary Outcomes (1)

• Overall survival rate (OS)

  From admission to the end of follow up, up to 2 years.

Study Arms (1)

Treatment group

EXPERIMENTAL

CD276 targeted chimeric antigen receptor cells treatment

Biological: CD276 CAR-T cells

Interventions

CD276 CAR-T cells BIOLOGICAL

CD276 CAR-T cells infusion

Treatment group

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years old (≥18 years old, ≤75 years old), no gender limit;
• The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
• Unresectable, locally advanced recurrence or metastatic pancreatic cancer diagnosed by histopathological examination; according to the American Joint Committee on Cancer (AJCC) TNM staging system (2017 version 8), diagnosed as stage III or IV pancreatic cancer ；
• According to the RECIST 1.1 standard, there are clear measurable and evaluable lesions;
• The tumor tissue was confirmed by immunohistochemical staining, and CD276 expression was positive;
• The subject must have received first-line treatment;
• The subject must be unsuitable for radical treatment, such as radical chemotherapy and/or surgery/immune checkpoint inhibitors, or refuse surgical resection
• Within 2 weeks before cell therapy, have not received antibody drug treatment;
• The ECOG score is 0-2 points;
• The subject has no contraindications for peripheral blood apheresis;
• The expected survival time is more than 3 months

You may not qualify if:

• Those who have a history of allergies to any of the ingredients in cell products;
• Routine blood examinations have the following conditions: WBC≦1×109/L, absolute centrioles ANC≦0.5×109/L, absolute lymphocyte value ALC≦0.5×109/L, PLT≦25×109/L;
• The following conditions in laboratory tests include, but are not limited to, serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl;
• According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) \<50%;
• Abnormal lung function, blood oxygen saturation in indoor air \<92%;
• Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina pectoris, or other serious clinical heart diseases within 12 months before enrollment;
• High blood pressure level 3 and poor blood pressure control with medication;
• Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
• Patients with autoimmune diseases, immunodeficiencies, or other patients who need immunosuppressive therapy;
• There is an uncontrolled active infection;
• Have used any CAR-T cell products or other genetically modified T cell therapies before;
• Live vaccination within 4 weeks before enrollment;
• HIV, HBV, HCV and TPPA/RPR infected persons, and HBV carriers;
• The subject has a history of alcoholism, drug abuse or mental illness;
• The subject has participated in any other clinical research within 3 months before joining this clinical research;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Li Yu

Shenzhen, Guangdong, 518000, China

RECRUITING

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu

CONTACT

+8675521839178; liyu@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)