Liver CancerPhase 1NCT05123209
Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients With Advanced Liver Tumors
A Phase 1 study testing IM83 CAR-T cells and The second-line treatment of liver cancer in people with Liver Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- IM83 CAR-T cells and The second-line treatment of liver cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2021to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- 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%.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA GENERAL HOSPITAL
Beijing, Beijing Municipality, 100039
Jianming Xu, M.D., +8613910866712, Jianmingxu2014@163.com
Jianming Xu, M.D.
About this study
Official title: Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients Wirh Advanced Liver Tumors
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
- Being tested
- IM83 CAR-T cells, The second-line treatment of liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM83 CAR-T cellsBiological
3×10^9 CAR-T cells
The second-line treatment of liver cancerCombination product
approved by NMPA
| Study group | Role | What they receive |
|---|---|---|
| IM83 CAR-T cells | Experimental | Not described Receives: Biological: IM83 CAR-T cells |
| IM83 CAR-T cells +The second-line treatment | Experimental | Not described Receives: Biological: IM83 CAR-T cells; Combination Product: The second-line treatment of liver cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
Measured: Up to 28 days after CAR-T cell infusion
Secondary outcomes (6)
Objective response rate (ORR)
ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1
Measured: At 28 days, 3 months and 6 months after CAR-T cell infusion
Duration of Response (DOR)
DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1
Measured: Up to 24 weeks after CAR-T cell infusion
Progression-free survival (PFS)
PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to RECIST v1.1
Measured: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
OS , defined as the time from CAR-T cell infusion to death from any cause
Measured: Up to 24 weeks after CAR-T cell infusion
Plasma levels of α fetoprotein (AFP) cells infusion
Measured: At 28 days, 3 months and 6 months after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)
The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.
Measured: Up to 24 weeks after CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start24 Aug 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123209
- Sponsor's protocol ID
- YMCART202101
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients Wirh Advanced Liver Tumors
- ClinicalTrials.gov ID
- NCT05123209
- Acronym / sponsor ID
- YMCART202101
- Conditions
- Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IM83 CAR-T cells3×10^9 CAR-T cells | Biological | IM83 CAR-T cells, IM83 CAR-T cells +The second-line treatment |
| The second-line treatment of liver cancerapproved by NMPA | Combination product | IM83 CAR-T cells +The second-line treatment |
Primary outcome
Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
Time frame: Up to 28 days after CAR-T cell infusion
6 secondary outcomes
Objective response rate (ORR)
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Duration of Response (DOR)
Time frame: Up to 24 weeks after CAR-T cell infusion
Progression-free survival (PFS)
Time frame: Up to 24 weeks after CAR-T cell infusion
Overall survival (OS)
Time frame: Up to 24 weeks after CAR-T cell infusion
Plasma levels of α fetoprotein (AFP) cells infusion
Time frame: At 28 days, 3 months and 6 months after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)
Time frame: Up to 24 weeks after CAR-T cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IM83 CAR-T cells and The second-line treatment of liver cancer in people with Liver Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Wu, MD (+8615801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0 (time frame: Up to 28 days after CAR-T cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.