Clinical trial NCT05605197: U87 CART in Treatment of Advanced Solid Tumor
Official title: Clinical Study to Evaluate the Safety and Efficacy of U87 CART in Treatment of Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pancreatic Cancer
Solid Tumor, Adult
Lead sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai 10th People's Hospital
First posted: 2022-11-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]
timeFrame: 28 days post administration of CAR-T-cells
Secondary outcomes:
measure: Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
timeFrame: 2 years post CAR T cell infusion
measure: Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]
timeFrame: 2 years post CAR T cell infusion
measure: Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness]
timeFrame: 2 years post CAR T cell infusion
measure: Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness]
timeFrame: 2 years post CAR T cell infusion
measure: Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness]
timeFrame: 2 years post CAR T cell infusion
measure: Pharmacokinetics of U87 CAR-T cells
timeFrame: 2 years post CAR T cell infusion
measure: Pharmacokinetics of U87 CAR-T cells
timeFrame: 2 years post CAR T cell infusion
measure: Pharmacokinetics of U87 CAR-T cells
timeFrame: 2 years post CAR T cell infusion
measure: Pharmacodynamics of U87 CAR-T cells
timeFrame: 2 years post CAR T cell infusion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: China Shanghai 10th People's Hospital
Study officials:
References: