Health TrialsbyHealthPanel

TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors

ConditionsNonsmall Cell Lung CancerSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

Tumor organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with advanced lung tumor or other solid tumor where biopsy is obtainable

Life expectancy >12 weeks

Child-Pugh-Turcotte score <7

Adequate heart,lung,liver,kidney function

Disqualifiers

Had accepted gene therapy before;

Tumor size more than 25cm;

Severe virus infection such as HBV, HCV, HIV, et al

Known HIV positivity

Trial design

Design model

Single group

Treatments tested in this trial

  • TCR-T cells

    Biological/Vaccine

    Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TCR-T cell therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Patients with Dose Limiting Toxicity

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the TCR-T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Time frame
three months

Secondary outcomes

1

Percent of Patients with best response as either complete remission or partial remission

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Time frame
three months

Other outcomes

1

Median TCR-T cell persistence

Median TCR-T cell persistence will be measured by quantitative rt-PCR.

Time frame
Five years

Sponsors and contacts

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

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Tcell Immune (Guangzhou) Science and Technology Ltd.

Collaborator

Source ClinicalTrials.gov
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