Who is sponsoring NCT02459067?

NCT02459067 is sponsored by TC Biopharm.

What condition does NCT02459067 study?

NCT02459067 studies Malignant Melanoma, Non-small Cell Lung Cancer, Renal Cell Cancer.

What is the status of NCT02459067?

NCT02459067 is currently TERMINATED.

Last reviewed 2022-03-08 · How we verify

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

NCT02459067 Phase 2 TERMINATED

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.

Details

Lead sponsor	TC Biopharm
Phase	Phase 2
Status	TERMINATED
Enrolment	8
Start date	2015-12
Completion	2018-11-27

Conditions

Malignant Melanoma
Non-small Cell Lung Cancer
Renal Cell Cancer

Interventions

ImmuniCell®

Primary outcomes

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

Countries

United Kingdom