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Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195294
Recruitment Status : Not yet recruiting
First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Lion TCR Pte. Ltd.

Study Description
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Brief Summary:
This is a single arm, open-label and multi-center Phase 1b/2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer, Adult Liver Cell Carcinoma Biological: LioCyx-M Drug: Lenvatinib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Phase 1b/2 Study for Autologous T Cells Transfected With mRNA Encoding HBV Antigen-specific TCR (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for Advanced HBV-related Hepatocellular Carcinoma
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: LioCyx-M monotherapy
Patients will receive up to 8 biweekly infusions of HBV antigen specific TCR redirected T cells (LioCyx-M).
 Biological: LioCyx-M
HBV antigen specific TCR redirected T cells
Experimental: LioCyx-M + lenvatinib combinational therapy
Patients will receive up to 8 biweekly infusions of HBV antigen specific TCR redirected T cells (LioCyx-M) with daily intake of lenvatinib.
 Biological: LioCyx-M
HBV antigen specific TCR redirected T cells

Drug: Lenvatinib
12 mg once daily for patients ≥60 kg, 8 mg for patients <60kg by oral


Outcome Measures
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Primary Outcome Measures :
  1. Assessments of adverse events/serious adverse events [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the safety of LioCyx-M as a monotherapy and in combination with lenvatinib

  2. Objective response rate (ORR) [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

  2. Time to radiographic progression (TTRP) [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

  3. Duration of response (DoR) [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

  4. Overall survival (OS) [ Time Frame: Up to 4 years from study treatment initiation ]
    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  2. Advanced HCC with diagnosis confirmed by histology/ cytology or clinically by AASLD criteria in cirrhotic patients.
  3. Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
  4. Patients who failed first-line systemic therapy for HCC
  5. Serum HBsAg positivity
  6. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
  7. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptor

Exclusion Criteria:

  1. Brain metastasis
  2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumours.
  3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
  4. History of severe allergic anaphylactic reactions to T cell therapy products and/or lenvatinib
  5. Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks before the first infusion of LioCyx-M.
  6. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, tyrosine kinase inhibitor therapy, and immunotherapy.
  7. Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to first infusion. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis.
  8. Treatment with other investigational therapy within 28 days prior to initiation of study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
  9. Likelihood to require any immunosuppressive treatments during the period of the clinical trial (Localized steroid use should be allowed)
  10. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for HBV)
  11. Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina
  12. Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic pressure >110 mmHg, despite optimal medical management
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195294


Contacts
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Contact: Royce Fam +65 6926 0818 royce.fam@liontcr.com

Sponsors and Collaborators
Lion TCR Pte. Ltd.
More Information
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Responsible Party: Lion TCR Pte. Ltd.
ClinicalTrials.gov Identifier: NCT05195294    
Other Study ID Numbers: LTCR-HCC-3-4
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lion TCR Pte. Ltd.:
TCR T cells
Hepatocellular Carcinoma
HBV
Hepatitis B virus
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action