Adaptive Study of the Safety, Tolerability & Efficacy of Autologous γδ T Lymphocyte Therapy (ImmuniCell®) in Patients With Advanced Cancers Refractory to Current Treatment or Have Indolent Disease for Which Immunotherapy May be Beneficial
Sponsor study identifier
interventional
8
1 country
7
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 27, 2018
Actual (reported)Study Completion
November 27, 2018
Actual (reported)To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage 2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 27, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2015
Actual (reported)June 1, 2015
Actual (reported)December 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 27, 2018
Actual (reported)November 27, 2018
Actual (reported)Proportion of patients with drug-related > grade 3 toxicity (except for nausea, vomiting or grade 3 diarrhoea without maximal supportive therapy; anaemia, alopecia, or asymptomatic grade 3 laboratory findings that last for < 7 days)
3 months
Document the clinical response (immediate or delayed CR, PR, SD or PD) of the patients following ImmuniCell® treatment and assess the data for a response signal to guide the confirmatory stage
12 months
Changes in markers of immune response (such as IFN-γ, IL-2 and TNF-α) before the first and subsequent ImmuniCell® infusions
12 months
Changes in peripheral T lymphocyte counts before the first and subsequent ImmuniCell® infusions (optional)
12 months
Subjects will receive 6 cycles of ImmuniCell®, one infusion over an hour, at two-week intervals. During Stage 1, intra-patient dose escalation to achieve a total dose of 30 x 109 γδ T cells.
Autologous γδ T Lymphocytes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Velindre Cancer Centre and University Hospital of Wales
Cardiff, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St. James's University Hospital
Leeds, United Kingdom
University College London Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Jeff Evans, Prof.
Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN
8 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2015
First Posted
June 1, 2015
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 27, 2018
Actual (reported)Study Completion
November 27, 2018
Actual (reported)Last Updated
March 10, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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