Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients With Advanced Liver Tumors
NCT ID: NCT05123209
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2021-08-24
2023-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IM83 CAR-T cells
IM83 CAR-T cells
3×10\^9 CAR-T cells
IM83 CAR-T cells +The second-line treatment
IM83 CAR-T cells
3×10\^9 CAR-T cells
The second-line treatment of liver cancer
approved by NMPA
Interventions
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IM83 CAR-T cells
3×10\^9 CAR-T cells
The second-line treatment of liver cancer
approved by NMPA
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, Barcelona stage B-C.
* Progression or intolerance after receiving standardized systematic treatment in the past (at least first-line treatment fails, and PD-1 / PD-L1 drugs can be used).
* Patients in car-t combined treatment group need to have not received the combined drugs before.
* At least one measurable target lesion according to RECIST1.1.
* Tumor cells expressed GPC3 antigen.
* Child Pugh score of liver function ≤ 7.
* ECOG 0-1.
* Estimated survival ≥ 12 weeks;
* Laboratory inspection shall at least meet the following specified indicators:
ANC≥ 1.5 × 10 \^ 9 / L，platelet ≥ 75 × 10 \^ 9 / L ，Hemoglobin ≥ 90 g / L，Serum creatinine ≤ 1.5 ULN，serum bilirubin ≤ 3 ULN，INR≤ 2，AST and ALT)≤ 5.0 ULN，Creatinine clearance rate ≥ 60 ml / min.
* The left ventricular ejection fraction was \> 50%.
Exclusion Criteria
* History of epilepsy or other central nervous system diseases that may affect the test in the judgment of the investigator.
* The washout period of chemotherapy, molecular targeted therapy, immunotherapy, hepatic artery chemoembolization, radiofrequency ablation, radiotherapy for non target lesions or other anti-tumor drugs within 1 week before blood collection is less than 5 half lives.
* Systemic glucocorticoids (local use is allowed) or other immunosuppressants were used within 3 days before apheresis.
* Other incurable malignant tumors in the past 5 years or at the same time, except cervical carcinoma in situ, skin basal cell carcinoma and breast ductal carcinoma in situ.
* The investigator assessed that the subject had poorly controlled pleural effusion, ascites or pericardial effusion.
* Hypertension with poor drug control (systolic blood pressure \> 160mmhg and / or diastolic blood pressure \> 90mmHg) or cardiovascular and cerebrovascular diseases with clinical significance (such as active) within 6 months before signing the informed consent, such as cerebrovascular accident, myocardial infarction, unstable angina pectoris, or severe arrhythmia, which cannot be controlled by drugs or has potential impact on the study treatment.
* Combined with other serious organic diseases or mental diseases.
* Subjects with HBsAg or HBcAbpositive and peripheral blood HBV DNA titers of \>2000 IU/ml (HBsAg positive but HBV DNA titer \<2000 IU/ml of peripheral blood and eligible for antiviral treatment according to chronic hepatitis B prevention guideline 2019 Edition). HCV antibody positive and HCV RNA in peripheral blood \> 500 IU / ml. Syphilis antibody positive.
* Male subjects who are pregnant or breastfeeding during the screening period, or who plan pregnancy during treatment or within 1 year after the end of treatment, or whose partner plans pregnancy within 1 year after the end of treatment.
* There were active or uncontrollable infections requiring systemic treatment within 1 week before cell apheresis.
* Other researchers believe that it is not suitable for inclusion.
18 Years
ALL
No
Sponsors
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Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese PLA GENERAL HOSPITAL
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianming Xu, M.D.
Role: primary
Other Identifiers
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YMCART202101
Identifier Type: -
Identifier Source: org_study_id