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Clinical Trial Record

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U87 CART in Treatment of Advanced Solid Tumor

2022-10-19

2024-12-31

2025-10-08

12

Study Overview

U87 CART in Treatment of Advanced Solid Tumor

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

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.

  • Pancreatic Cancer
  • Solid Tumor, Adult
  • DRUG: U87 CAR-T
  • U87-3

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-10-03  

N/A  

2024-05-23  

2022-10-29  

N/A  

2024-05-28  

2022-11-04  

N/A  

2023-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: U87 CAR-T cells

The Patients are enrolled into 2 dose level cohorts in sequence

DRUG: 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability]Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Dose-limiting toxicity after U87 CAR-T cells infusion.28 days post administration of CAR-T-cells
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]Disease control rate: including CR, PR and SD(Assessed based on RECIST 1.1 criteria)2 years post CAR T cell infusion
Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]Objective response rate includes：CR、PR(Assessed based on RECIST1.1 criteria)2 years post CAR T cell infusion
Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness]DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause2 years post CAR T cell infusion
Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness]PFS will be assessed from the first U87 CAR-T cells infusion to death from any cause or the first assessment of progression(Assessed based on RECIST1.1 ） criteria)2 years post CAR T cell infusion
Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness]OS will be assessed from the first U87 CAR-T cells infusion to death from any cause (Assessed based on RECIST 1.1 criteria)2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cellsPeak value of eripheral blood (Cmax)2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cellsArea under the eripheral blood concentration versus time curve (AUC)2 years post CAR T cell infusion
Pharmacokinetics of U87 CAR-T cellsTime of peak value2 years post CAR T cell infusion
Pharmacodynamics of U87 CAR-T cellsConcentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, IL-2, TNFα, ferritin and CRP at each time point2 years post CAR T cell infusion

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Maoquan Li, doctor

Phone Number: 021-66300114*3506

Email: cjr.limaoquan@vip.163.com

Study Contact Backup

Name: Shilong Han, doctor

Phone Number: 021-66303247

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Shanghai 10th People's Hospital
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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