Using U87 CAR-T therapy for advanced solid tumors

Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor

This study is testing a new treatment using modified immune cells to see if it can help people with advanced pancreatic cancer feel better and improve their outcomes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (Industry-sponsored)
• Drugs / interventions: CART
• Locations: 1 site (Shanghai)
• Trial ID: NCT05605197 on ClinicalTrials.gov

What this trial studies

This phase 1 clinical trial evaluates the safety and efficacy of U87 CAR-T therapy in patients with advanced solid tumors, specifically pancreatic cancer. Eligible participants will undergo a leukapheresis procedure to collect their own immune cells, which will be modified to target U87 specific antigens. After the modified cells are produced, patients will receive a preconditioning regimen followed by the infusion of the U87 CAR-T cells. Long-term follow-up will be conducted to monitor gene safety and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed advanced solid tumors who have failed or are intolerant to first-line therapy.

Not a fit: Patients with early-stage tumors or those who have not yet undergone first-line therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: Other studies using CAR-T therapies have shown promising results in treating various cancers, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Voluntary informed consent is given;
2. Age 18 to 75;
3. Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy;
4. Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%);
5. Expected survival ≥12 weeks;
6. Measurable tumor lesions according to RECIST 1.1;
7. ECOG performance score 0-1;
8. Sufficient venous access for mononuclear cell collection;
9. HBc Ab positive, HBsAg negative can be included in the group when the PCR detection of HBV DNA is negative;
10. Patients should maintain adequate organ function;
11. Dyspnea (CTCAE v5.0) ≤ Grade 1; Blood oxygen saturation\>91% without oxygen inhalation;
12. Pregnancy test was negative in women of childbearing age; Both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year;

Exclusion Criteria:

1. Pregnant or lactating women;
2. Uncontrolled active infections;
3. Active Syphilis, HIV, hepatitis B or hepatitis C infection;
4. Congenital immunodeficiency;
5. Have serious allergic reaction to any drug to be used in this study;
6. Other incurable malignant tumors in the past three years;
7. History or presence of clinically relevant CNS pathology such as epilepsy, Cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease;
8. Have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases;
9. Subjects requiring anticoagulation or long-term antiplatelet therapy;
10. Subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study.
11. Other situations that the investigator thinks are not suitable for participating in this study.

Where this trial is running

Shanghai

• China Shanghai 10th People's Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Maoquan Li, doctor

Conditions Pancreatic Cancer; Solid Tumor, Adult