U87 CART in Treatment of Advanced Solid Tumor

Shanghai Unicar-Therapy Bio-medicine Technology

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor, Adult; Pancreatic Cancer

Treatments: Drug: U87 CAR-T

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05605197

U87-3

Details and patient eligibility

About

This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .

Full description

Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

U87 CAR-T cells

Experimental group

Description:

The Patients are enrolled into 2 dose level cohorts in sequence

Treatment:

Drug: U87 CAR-T