Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients With Advanced Liver Tumors

NCT05123209 | Unknown Phase 1

• 1 other identifier: YMCART202101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a open-label, single center, cohort study to determine the efficacy and safety of IM83 CAR-T cells in patients with advanced Liver Tumors.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0

  Up to 28 days after CAR-T cell infusion

Secondary Outcomes (6)

• Objective response rate (ORR)

  At 28 days, 3 months and 6 months after CAR-T cell infusion

• Duration of Response (DOR)

  Up to 24 weeks after CAR-T cell infusion

• Progression-free survival (PFS)

  Up to 24 weeks after CAR-T cell infusion

• Overall survival (OS)

  Up to 24 weeks after CAR-T cell infusion

• Plasma levels of α fetoprotein (AFP) cells infusion

  At 28 days, 3 months and 6 months after CAR-T cell infusion

Study Arms (2)

IM83 CAR-T cells

EXPERIMENTAL

Biological: IM83 CAR-T cells

IM83 CAR-T cells +The second-line treatment

EXPERIMENTAL

Biological: IM83 CAR-T cells; Combination Product: The second-line treatment of liver cancer

Interventions

IM83 CAR-T cells BIOLOGICAL

3×10\^9 CAR-T cells

IM83 CAR-T cells; IM83 CAR-T cells +The second-line treatment

The second-line treatment of liver cancer COMBINATION_PRODUCT

approved by NMPA

IM83 CAR-T cells +The second-line treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old, male or female.
• 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%.

You may not qualify if:

• The researcher has determined that the subject has autoimmune diseases that are not suitable to participate in this study, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis.
• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Chinese PLA GENERAL HOSPITAL

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058; wufei@immunochina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: November 17, 2021
• Study Start: August 24, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)