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Trial Title:
U87 CART in Treatment of Advanced Solid Tumor
NCT ID:
NCT05605197
Condition:
Pancreatic Cancer
Solid Tumor, Adult
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
U87 CAR-T
Description:
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.
Arm group label:
U87 CAR-T cells
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China Shanghai 10th People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Li mao quan, doctor
Phone:
021-66300114
Phone ext:
3506
Email:
cjr.limaoquan@vip.163.com
Start date:
October 19, 2022
Completion date:
October 8, 2025
Lead sponsor:
Agency:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Agency class:
Industry
Collaborator:
Agency:
Shanghai 10th People's Hospital
Agency class:
Other
Source:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05605197
