Health TrialsbyHealthPanel

Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuangzhou FineImmune Biotechnology Co., LTD.

About this trial

The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .

The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 70 years old, regardless of gender;

Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;

Be after standard treatment or who lack effective treatment programs;

Patients and their families were willing to participate in the clinical trial and signed the informed consent;

Disqualifiers

Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);

Experiencing moderate to severe infection or possible opportunistic infection;

Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);

Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;

Trial design

Design model

Single group

Treatments tested in this trial

  • tumor-specific TCR-T cells

    Drug

    On day 0 and day 14, 0.5-5x10\^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.

  • Interleukin-2

    Drug

    Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TCR-T cell infusionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Keep records the adverse events experienced by subjects in 30 days after the last infusion.

Time frame
At least 45 days

Secondary outcomes

1

Disease Control Rate(DCR)

DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST

Time frame
one year
2

overall survival(OS)

The time from the first injection of Investigational Product until death

Time frame
two year
3

progression-free survival(PFS)

PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST

Time frame
two year

Other outcomes

Sponsors and contacts

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

Guangzhou FineImmune Biotechnology Co., LTD.

Lead sponsor

Sun Yat-Sen University Cancer Center

Collaborator

Source ClinicalTrials.gov
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