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UNKNOWNPHASE1

U87 CART in Treatment of Advanced Solid Tumor

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

NCT05605197•Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

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

Age

18 - 75 years

Sex

ALL

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;
+2 more criteria

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.
+1 more criteria

Locations (1)

China Shanghai 10th People's Hospital

Shanghai, China

Key Dates

Start Date

October 19, 2022

Primary Completion Date

December 31, 2024

Completion Date

October 8, 2025

Last Updated

May 28, 2024

Enrollment

ESTIMATED participants

Conditions

Pancreatic CancerSolid Tumor, Adult

Interventions

U87 CAR-T

DRUG

Contacts

Maoquan Li, doctor

CONTACT

021-66300114*3506 cjr.limaoquan@vip.163.com

Shilong Han, doctor

CONTACT

021-66303247

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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U87 CART in Treatment of Advanced Solid Tumor

Inclusion Criteria

Exclusion Criteria

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