Clinical Trials /

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

NCT03971747

Description:

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

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: AFP Specific T Cell Receptor Transduced T Cells Injection(C-TCR055) in Unresectable Hepatocellular Carcinoma
  • Official Title: A Phase 1 Study of AFP Specific T Cell Receptor Transduced T Cells Injection in Unresectable Hepatocellular Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 0421-011
  • NCT ID: NCT03971747

Conditions

  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
AFP Specific T Cell Receptor T CellsC-TCR055

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
C-TCR055ExperimentalAutologous C-TCR055 administered by intravenous (IV) infusion
  • AFP Specific T Cell Receptor T Cells

Eligibility Criteria

        Inclusion Criteria:

          1. Able to provide written informed consent.

          2. Age 18-70 years old, male or female.

          3. Patients must meet the following criteria:

               1. Histologically confirmed HCC

               2. Serum AFP >200 ng/mL

               3. Child-Pugh score ≤6

               4. BCLC stage B and stage C or stage Ⅱa/Ⅱb and Ⅲa/Ⅲb defined by Chinese Liver Cancer
                  Guideline(2017)

               5. Clinical confirmed relapse or progression if patient had locoregional therapy
                  previously

               6. 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.

               7. 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.

               8. Previous systemic therapy was discontinued at least 2 weeks before apheresis.

          4. Has at least 1 measurable lesion as defined per RECIST v1.1.

          5. HLA-A0201 allele positive.

          6. Liver AFP expression IHC tests:

               1. >=20% tumor cells positive, and <=5% non-tumor tissue positive;

               2. serum AFP >=400ng/ml, and <=5% non-tumor tissue positive.

          7. Laboratory criteria:

               1. Absolute neutrophil count (ANC) ≥ 1.5x10^9/ L

               2. Platelets≥ 60x10^9/L

               3. Hemoglobin≥ 90g/L

               4. Serum total bilirubin ≤ 2 x ULN

               5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 x ULN

               6. Creatinine ≤1.5×ULN

               7. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 x ULN

          8. ECOG score ≤ 1.

          9. Left ventricular ejection fraction (LVEF) ≥ 50% (measured by echocardiography).

         10. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92%
             on room air.

         11. Expected survival > 12 weeks.

         12. 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.

         13. 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.

        Exclusion Criteria:

          1. Have a history of allergy to cellular products.

          2. Subject has liver transplantation history.

          3. Medium to severe ascites.

          4. Subject has other primary cancer except for the following:

             A. 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

          5. Significant clinical gastrointestinal bleeding within 4 weeks before treatment.

          6. Subjects with bone metastasis or central nervous system metastasis, or with hepatic
             encephalopathy, epilepsy, cerebrovascular accident and other central nervous system
             involvement diseases.

          7. Prior treatment with genetically modified T cell therapy or stem cell therapy.

          8. Uncontrolled active infection. Preventive antibiotics, antiviral and antifungal are
             permitted.

          9. Active hepatitis virus infection. HCV RNA positive.

         10. Subjects with syphilis or other acquired, congenital immunodeficiency disorders,
             including, but not limited to, HIV infected persons, systemic lupus erythematosus,
             psoriasis, etc.

         11. Heart insufficiency subjects of Grade III or IV according to NYHA classification
             criteria.

         12. Any other disease that may increase the risk of the subject or interfere with the
             results of the study.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment related adverse events as assessed by CTCAE v4.0[Safety of C-TCR055]
Time Frame:start treatment to 12 months
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:ORR
Time Frame:3 months and 6 months
Safety Issue:
Description:Overall response rate based on RECIST v1.1
Measure:DOR
Time Frame:12 months
Safety Issue:
Description:Duration of remission
Measure:PFS
Time Frame:12 months
Safety Issue:
Description:Progression free survival
Measure:OS
Time Frame:6 months and 12 months
Safety Issue:
Description:Overall survival

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Cellular Biomedicine Group Ltd.

Trial Keywords

  • Liver Cancer

Last Updated

June 2, 2019