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Hepatocellular CarcinomaPhase 1NCT03971747

AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular Carcinoma

A Phase 1 study testing AFP Specific T Cell Receptor T Cells in people with Hepatocellular Carcinoma, run by Shanghai AbelZeta Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase 1 study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
AFP Specific T Cell Receptor T Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
6 Aug 2019to Apr 2021
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent.
  • Age 18-70 years old, male or female.
  • Patients must meet the following criteria:
  • Histologically confirmed HCC
  • Serum AFP >200 ng/mL
  • Child-Pugh score ≤6
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  • BCLC stage B and stage C or stage Ⅱa/Ⅱb and Ⅲa/Ⅲb defined by Chinese Liver Cancer Guideline（2017）
  • Clinical confirmed relapse or progression if patient had locoregional therapy previously
  • Systemic therapy failed HCC Subject: those who received standardized systemic treatment for unresectable HCC and subsequently relapsed/progressed, or were intolerable or unwilling to receive treatment. Front-line system treatment should be approved in China (sorafenib, lenvastinib, platinum-containing chemotherapy regimen, regofinil)
  • . Local treatment (including surgery, ablation, interventional therapy, local radiotherapy, etc.) must be completed at least 4 weeks before apheresis, and there is no unhealed wound.
  • Previous systemic therapy was discontinued at least 2 weeks before apheresis.
  • Has at least 1 measurable lesion as defined per RECIST v1.1.
  • HLA-A 02:01 allele positive.
  • Liver AFP expression IHC tests:
  • ≥20% tumor cells positive, and ≤5% non-tumor tissue positive;
  • serum AFP ≥400ng/ml, and ≤5% non-tumor tissue positive.
  • ECOG score ≤ 1.
  • Expected survival > 12 weeks
  • Left ventricular ejection fraction (LVEF) ≥ 50% (measured by echocardiography).
  • No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  • Laboratory criteria
  • Absolute neutrophil count (ANC) ≥ 1.5x10^9/ L
  • Platelets≥ 60x10^9/L
  • Hemoglobin≥ 90g/L
  • Serum total bilirubin ≤ 2 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 x ULN
  • Creatinine ≤1.5×ULN
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5 x ULN
  • If patient has previous HBV infection, patient should receive antivirals treatment following treatment guidelines during study period, and the HBV DNA copies should below the detection limit at screening.
  • Female subjects in childbearing age, their serum or urine pregnancy test must be negative, all subjects must agree to take effective contraceptive measures during the trial.
  • Agree to abstain from alcohol during the study period
  • No contraindications for apheresis
  • Apheresis was received by laboratory ,and passed QC

Who cannot join

  • Have a history of allergy to cellular products.
  • Subject has liver transplantation history.
  • tumor volume was greater than 70% of liver tissue
  • main portal vein carcinoma thrombus
  • Medium to severe ascites.
  • subjects received other anti-tumor systemic therapy except standard systemic therapy. Or subjects received immunocheckpoint inhibitors was less than 6 weeks or 2 drug half-lives.
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  • Subject has other primary cancer except for the following:
  • Non-melanoma cured by excision, such as basal cell skin cancer. B. Cured in situ cancers such as cervical cancer, bladder cancer or breast cancer
  • Significant clinical gastrointestinal bleeding within 4 weeks before treatment.
  • Subjects with bone metastasis or central nervous system metastasis, or with hepatic encephalopathy, epilepsy, cerebrovascular accident and other central nervous system involvement diseases.
  • Prior treatment with genetically modified T cell therapy or stem cell therapy.
  • Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are permitted.
  • Active hepatitis virus infection. HCV RNA positive.
  • Subjects with syphilis or other acquired, congenital immunodeficiency disorders, including, but not limited to, HIV infected persons, systemic lupus erythematosus, psoriasis, etc.
  • Heart insufficiency subjects of Grade III or IV according to NYHA classification criteria.
  • Subjects received systemic therapeutic steroid doses (except for the recent or current use of inhaled steroids) or other immunotherapy (such as interleukin-interferon, thymosin, etc.) within 2 weeks before Leukocyte apheresis.
  • Subjects received radiotherapy within 6weeks before Leukocyte apheresis
  • Subjects who are pregnant, lactating, or pregnant within 6 months
  • Any other disease that may increase the risk of the subject or interfere with the results of the study.

Trial locations and contacts

1 site in 1 country.

Yuhong Zhou, MD, Ph.D contact

86-021-64041990

zhou.yuhong@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Fudan University Affiliated ZhongShan Hospital

    Shanghai, Shanghai Municipality, 200032

    Yuhong Zhou, Ph.D, zhou.yuhong@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma

A phase 1 study that aimed to assess the safety and anti-tumor activity of C-TCR055 injection in unresectable HCC patients.

Read the detailed description

This study plans to enroll 9 patients to assess the safety of C-TCR055. Subjects who meet the eligibility criteria will receive a single dose of C-TCR055 injection, and will be followed up post treatment for safety monitoring. The follow up period will last 12 months.

Being tested
AFP Specific T Cell Receptor T Cells
Keywords
Liver Cancer
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFP Specific T Cell Receptor T CellsBiological

    Autologous T cells transduced with lentivirus encoding AFP specific TCR gene

Study groups in NCT03971747
Study groupRoleWhat they receive
C-TCR055ExperimentalAutologous C-TCR055 administered by intravenous (IV) infusion
Receives: Biological: AFP Specific T Cell Receptor T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related adverse events as assessed by CTCAE v4.0[Safety of C-TCR055]

    Determine if treatment with C-TCR055 is safe through assessment of adverse events(AEs) and serious adverse events(SAEs) as assessed by CTCAE v4.0

    Measured: start treatment to 12 months

Secondary outcomes (4)

  1. ORR

    Overall response rate based on RECIST v1.1

    Measured: 3 months and 6 months

  2. DOR

    Duration of remission

    Measured: 12 months

  3. PFS

    Progression free survival

    Measured: 12 months

  4. OS

    Overall survival

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2019
  2. Study start6 Aug 2019
  3. Primary completionJun 2020 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03971747
Sponsor's protocol ID
0421-011
Status last verified
Apr 2020
First submitted
28 May 2019
Last updated
7 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hussein MS, Li Q, Mao R, Peng Y, He Y. TCR T cells overexpressing c-Jun have better functionality with improved tumor infiltration and persistence in hepatocellular carcinoma. Front Immunol. 2023 May 4;14:1114770. doi: 10.3389/fimmu.2023.1114770. eCollection 2023.

    PubMed 37215108

  • Luo X, Cui H, Cai L, Zhu W, Yang WC, Patrick M, Zhu S, Huang J, Yao X, Yao Y, He Y, Ji Y. Selection of a Clinical Lead TCR Targeting Alpha-Fetoprotein-Positive Liver Cancer Based on a Balance of Risk and Benefit. Front Immunol. 2020 Apr 27;11:623. doi: 10.3389/fimmu.2020.00623. eCollection 2020.

    PubMed 32425926

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AFP Specific T Cell Receptor T Cells in people with Hepatocellular Carcinoma, run by Shanghai AbelZeta 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 33 inclusion and 19 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 7 Apr 2020. 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 Yuhong Zhou, MD, Ph.D (86-021-64041990, zhou.yuhong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse events as assessed by CTCAE v4.0[Safety of C-TCR055] (time frame: start treatment to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03971747, which also lists 2 linked publications.

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 7 Apr 2020.

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