U87 CART in Treatment of Advanced Solid Tumor

NCT ID: NCT05605197

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2025-10-08

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.

Conditions

Pancreatic Cancer; Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

U87 CAR-T cells

The Patients are enrolled into 2 dose level cohorts in sequence

Group Type: EXPERIMENTAL

U87 CAR-T

Intervention Type: DRUG

Subjects will be pretreated with cyclophosphamide 250\~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3\~6 patients.

Interventions

U87 CAR-T

Subjects will be pretreated with cyclophosphamide 250\~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3\~6 patients.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Shanghai 10th People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Maoquan Li, doctor

Role: CONTACT

cjr.limaoquan@vip.163.com

021-66300114*3506

Shilong Han, doctor

Role: CONTACT

021-66303247

Facility Contacts

Li mao quan, doctor

Role: primary

cjr.limaoquan@vip.163.com

021-66300114 ext. 3506

Other Identifiers

U87-3

Identifier Type: -

Identifier Source: org_study_id