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Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma

ConditionAdvanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University

About this trial

A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 80 years, male or female;

Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;

Pathologically diagnosed with hepatocellular carcinoma, patients with China liver Cancer Staging (CNLC) stageII-III.;

HCC patients who are not suitable for surgical resection or local treatment (including ablation therapy, interventional therapy, and radiation therapy), or who experience recurrence or progression after surgery and/or local treatment, and who have previously received at least second-line systematic standardized treatment and have progressed or are intolerant to it;

Disqualifiers

Active brain metastasis;

Patients who have received or are waiting for organ transplantation;

Active autoimmune diseases that require systemic immunosuppressive therapy within the past 2 years, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, etc;

Researchers evaluated that the proportion of intrahepatic tumors is greater than 50% of the entire liver; Or there may be tumor thrombus formation in the main portal vein, or tumor thrombus invasion into the mesenteric vein/inferior vena cava;

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-CD19 CAR-T

    Biological/Vaccine

    All subjects were intravenous administrated with CNCT19 CAR-T.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose limiting toxicity (DLT)

Describe the adverse events of limiting further increases in the dose of CNCT19.

Time frame
Within 28 days of CNCT19infusion
2

Adverse events

Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the studytreatment that occur at any time of 24 months after treatment.

Time frame
Within 24 months after the treatment
3

Maximum tolerated dose

Determine the optimal agent for CNCT19 at maximum tolerated dose.

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)

Secondary outcomes

1

Effectiveness evaluation

Objective response rate by RECIST 1.1.

Time frame
From treatment of the first subject to completion of follow-up of the last subject (up to 3 years)
2

Effectiveness evaluation

Progression-free survival by RECIST 1.1

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
3

Effectiveness evaluation

Duration of response by RECIST 1.1

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
4

Effectiveness evaluation

Time to response by RECIST 1.1

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Juventas Cell Therapy Ltd.

Collaborator

Source ClinicalTrials.gov
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