Hepatocellular CarcinomaPhase 1NCT05352646
NewishT Cell Therapy for HCC With High Risk of Recurrence After Radical Resection
A Phase 1 study testing Autologous memory lymphocyte Injection (NewishT), low-dose group and Autologous memory lymphocyte Injection (NewishT), high-dose group in people with Hepatocellular Carcinoma, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and efficacy of autologous memory lymphocyte therapy (NewishT) in patients with hepatocellular carcinoma at high risk of recurrence after radical resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Autologous memory lymphocyte Injection (NewishT), low-dose group and Autologous memory lymphocyte Injection (NewishT), high-dose group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2022to 31 Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had to meet all of the following inclusion criteria:
- 18≤ age ≤75, regardless of gender;
- Primary hepatocellular carcinoma, which was diagnosed in one of the following conditions: 1) Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology; 2) Meet the clinical diagnostic criteria of liver cancer in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition);
- HBsAg or HBV DNA positive serological test, active virus infection is willing to accept anti-HBV virus treatment during the study period;
- Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) IA-IIIA;
- Underwent radical resection of liver cancer (open surgery, laparoscopic surgery, ablation, robot-assisted surgery) within 12 weeks before blood sampling for the first NewishT preparation; The interval between clinical staging of BCLC or CNLC hepatocellular carcinoma and radical resection was less than 12 weeks.
Show all 34Show fewer
- No residual intrahepatic tumor was found by imaging examination within 4 weeks before blood sampling for the first NewishT preparation; No lymph node metastasis, no extrahepatic metastasis;
- Patients undergoing radical resection of liver cancer should meet the intraoperative criteria of radical resection of liver cancer:
- There was no invasion of adjacent organs, hilar lymph nodes or distant metastasis during the operation; (2) Negative cutting margin;
- 8. No Vp4 macrovascular invasion, hepatic vein or inferior vena cava macrovascular invasion of any grade after radical resection (see Appendix 12 for definition of macrovascular invasion);
- 9. Meeting any of the following high recurrence risk factors after radical mastectomy:
- Patients undergoing radical resection:
- Number of tumors ≥3;
- Single tumor patients: patients with tumor diameter ≥ 5cm;
- Single tumor patients: patients with tumor diameter < 5cm, pathological report showed Microvascular invasion (MVI) or Vp1/Vp2/Vp3 macrovascular invasion;
- Edmondson-Steiner grade Ⅲ or Ⅳ of hepatocellular carcinoma;
- Patients undergoing radical ablation:
- Patients with multiple tumors: the diameter of all tumors ≤5cm and the number of tumors ≤4;
- Single tumor patients: tumor diameter 2-5cm;
- Edmondson-Steiner grade Ⅲ or Ⅳ of hepatocellular carcinoma ;
- 10. Within 1 week before blood collection for the first NewishT preparation, ECOG performance status score was 0-1;
- 11. Child-Pugh score A/B (≤7) within 1 week before blood collection for the first NewishT preparation;
- 12. Major organ functions were normal within 1 week before blood collection for the first NewishT preparation:
- Blood routine:
- Hemoglobin (Hb) ≥75 g/L (no infusion of concentrated red blood cells or erythropoietin within 2 weeks); Absolute neutrophil count (ANC) ≥1.5×109/L (no granulocyte colony-stimulating factor was used within 2 weeks); Absolute lymphocyte count (LYMP) ≥0.8×109/L; (4) Platelet count (PLT) ≥50×109/L;
- The liver:
- Total bilirubin (TB) ≤3× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Plasma albumin ≥28g/L;
- Blood coagulation function:
- International normalized ratio (INR) ≤2.3;
- Kidney:
- Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min (serum creatinine \> 1.5 x ULN);
- 13. The expected survival time is more than 6 months;
- 14. Within 1 week before blood collection for the first NewishT preparation, women of childbearing age must have a negative serum pregnancy test and consent to use effective contraception during the use of the study drug and within 6 months after the last administration of the study drug. For men, they should be surgically sterilized or agree to use effective contraception during study drug use and for 6 months after the last administration of study drug.
- 15. Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
Who cannot join
- Patients with any of the following were excluded from the study:
- HCC recurred before blood collection for the first NewishT preparation;
- Before blood sampling for the first NewishT preparation, the investigator judged that the patient had not fully recovered from the toxicity and/or complications of radical resection;
- There are contraindications to TACE;
- After radical hepatectomy or during the screening period, received or planned to receive radiotherapy, chemotherapy, molecular targeted therapy, biological therapy, TACE therapy, radiofrequency ablation and other anti-liver cancer therapies (except postoperative TACE adjuvant therapy specified in the protocol);
- accompanied by hepatic encephalopathy;
Show all 25Show fewer
- Regular renal dialysis is required;
- with uncontrolled pleural effusion, pericardial effusion, or moderate or more ascites (refers to ascites that cannot be easily controlled by diuretic treatment);
- A history of gastrointestinal bleeding, current active bleeding, or bleeding tendency within 28 days before screening;
- had received systemic antitumor therapy (including chemotherapy, molecular targeted therapy, biological immunotherapy) for liver cancer within 28 days before screening;
- had undergone transcatheter arterial interventional therapy (transcatheter arterial chemoembolization [TACE], transcatheter arterial chemoembolization [TAE], transcatheter arterial infusion chemotherapy [HAIC], radioactive microsphere TACE[TARE], etc.), radiotherapy, microwave ablation, cryotherapy, high-power ultrasound focused ablation and other local treatments for liver tumors. Radical ablation and resection are excluded;
- Participated in another clinical trial or was under observation in another clinical trial within 28 days prior to screening;
- Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \> 10 mg/ day), except hormone replacement therapy and intratracheal administration;
- A history of immune deficiency or autoimmune diseases (e.g., rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
- A history of allogeneic stem cell/tissue/solid organ transplantation (including bone marrow transplantation);
- with uncontrolled severe infection (> grade 2 NCI-CTC adverse events, version 5.0);
- Persons with a history of hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection or carriers of syphilis;
- Patients with serious other organ dysfunction or cardiopulmonary diseases;
- epilepsy that requires treatment with medication (e.g. steroids or antiepileptic drugs);
- had or currently has other malignancies (with the exception of adequately treated and completely cured ductal carcinoma in situ of the breast, carcinoma in situ of the cervix, basal cell carcinoma of the skin, superficial bladder tumor, or any malignancy that was cured more than 5 years before study entry);
- a known history of albumin allergy, or severe allergy, or allergic disease, or allergic constitution, or severe iodine contrast allergy, meeting any of these criteria;
- severe mental illness;
- a history of drug or alcohol abuse;
- pregnant or lactating women, or women of childbearing age with positive blood pregnancy tests, or patients of childbearing age and their spouses are unwilling to use effective contraception during and within 6 months after the completion of the clinical study;
- Patients deemed by the investigator to be ineligible for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Hong Zhao, MD, 86-010-87787100, zhaohong@cicams.ac.cn
About this study
Official title: Autologous Memory Lymphocyte（NewishT）for Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection
This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and efficacy of autologous memory lymphocyte therapy (NewishT) in patients with hepatocellular carcinoma at high risk of recurrence after radical resection.
Read the detailed description
This study is divided into two dose groups and two phases. Phase Ia climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Phase Ib extended 10 subjects each group.
After the completion of treatment, the subjects shall continue to receive safety follow-up until 14 days after the last administration, and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved); Tumor imaging assessment was performed at week 7 and week 20 to observe the progression of disease.
After week 20, the survival follow-up period was entered, and patients were followed up until death, loss of follow-up, or trial termination, whichever occurred first. Survival was followed up by telephone every 12 weeks (±7 days), and radiographic evidence should be obtained if recurrence/progression occurred.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Autologous memory lymphocyte Injection (NewishT), low-dose group, Autologous memory lymphocyte Injection (NewishT), high-dose group
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous memory lymphocyte Injection (NewishT), low-dose groupDrug
Also called Low-dose group
Recruited participants in low-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 4 weeks, a total of 2 times.
Autologous memory lymphocyte Injection (NewishT), high-dose groupDrug
Also called High-dose group
Recruited participants in high-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 2 weeks, a total of 4 times.
| Study group | Role | What they receive |
|---|---|---|
| NewishT | Experimental | This study is divided into two dose groups and two phases. Phase Ia climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Phase Ib extended 10 subjects each group. Receives: Drug: Autologous memory lymphocyte Injection (NewishT), low-dose group; Drug: Autologous memory lymphocyte Injection (NewishT), high-dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicity (DLT)
Any AEs that is definitely, probably, or possibly related to the test drug occurring within 14 days of the last dosing will be classified as DLT during dosing climb.
Measured: 14 days after last administration
Secondary outcomes (2)
All adverse events (AE)
Including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events)
Measured: 1 year
recurrence-free survival(RFS) rate
The probability of no recurrence or death within 1 year from the date of radical hepatocellular carcinoma resection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start26 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianqiang Cai, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352646
- Sponsor's protocol ID
- NewishT-HCC-002
- Status last verified
- Sep 2023
- First submitted
- 24 Apr 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Memory Lymphocyte（NewishT）for Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection
- ClinicalTrials.gov ID
- NCT05352646
- Acronym / sponsor ID
- NewishT-HCC-002
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Apr 2022 (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 single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and efficacy of autologous memory lymphocyte therapy (NewishT) in patients with hepatocellular carcinoma at high risk of recurrence after radical resection.
Detailed description
This study is divided into two dose groups and two phases. Phase Ia climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Phase Ib extended 10 subjects each group.
After the completion of treatment, the subjects shall continue to receive safety follow-up until 14 days after the last administration, and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved); Tumor imaging assessment was performed at week 7 and week 20 to observe the progression of disease.
After week 20, the survival follow-up period was entered, and patients were followed up until death, loss of follow-up, or trial termination, whichever occurred first. Survival was followed up by telephone every 12 weeks (±7 days), and radiographic evidence should be obtained if recurrence/progression occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NewishT | Experimental | Drug: Autologous memory lymphocyte Injection (NewishT), low-dose group, Drug: Autologous memory lymphocyte Injection (NewishT), high-dose groupThis study is divided into two dose groups and two phases. Phase Ia climbed from low-dose group to high-dose group in turn according to the 3+3 dose escalation principle. Phase Ib extended 10 subjects each group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 18≤ age ≤75, regardless of gender;
- Primary hepatocellular carcinoma, which was diagnosed in one of the following conditions: 1) Hepatocellular carcinoma (HCC) confirmed by histopathology or cytology; 2) Meet the clinical diagnostic criteria of liver cancer in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition);
- HBsAg or HBV DNA positive serological test, active virus infection is willing to accept anti-HBV virus treatment during the study period;
- Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) IA-IIIA;
- Underwent radical resection of liver cancer (open surgery, laparoscopic surgery, ablation, robot-assisted surgery) within 12 weeks before blood sampling for the first NewishT preparation; The interval between clinical staging of BCLC or CNLC hepatocellular carcinoma and radical resection was less than 12 weeks.
Key exclusion criteria (25 listed)
- HCC recurred before blood collection for the first NewishT preparation;
- Before blood sampling for the first NewishT preparation, the investigator judged that the patient had not fully recovered from the toxicity and/or complications of radical resection;
- There are contraindications to TACE;
- After radical hepatectomy or during the screening period, received or planned to receive radiotherapy, chemotherapy, molecular targeted therapy, biological therapy, TACE therapy, radiofrequency ablation and other anti-liver cancer therapies (except postoperative TACE adjuvant therapy specified in the protocol);
- accompanied by hepatic encephalopathy;
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 |
|---|---|---|
| Autologous memory lymphocyte Injection (NewishT), low-dose groupAlso: Low-dose groupRecruited participants in low-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 4 weeks, a total of 2 times. | Drug | NewishT |
| Autologous memory lymphocyte Injection (NewishT), high-dose groupAlso: High-dose groupRecruited participants in high-dose group will receive autologous memory lymphocyte (NewishT) intravenous infusion every 2 weeks, a total of 4 times. | Drug | NewishT |
Primary outcome
dose-limiting toxicity (DLT)
Time frame: 14 days after last administration
Any AEs that is definitely, probably, or possibly related to the test drug occurring within 14 days of the last dosing will be classified as DLT during dosing climb.
2 secondary outcomes
All adverse events (AE)
Time frame: 1 year
recurrence-free survival(RFS) rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Jianqiang Cai principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Autologous memory lymphocyte Injection (NewishT), low-dose group and Autologous memory lymphocyte Injection (NewishT), high-dose group in people with Hepatocellular Carcinoma, run by Newish Technology (Beijing) 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 34 inclusion and 25 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 28 Sep 2023. 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 Defang Liu, Phd (13718744928, ldf@newishes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicity (DLT) (time frame: 14 days after last administration). 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 28 Sep 2023.