ImmuniCell® in Patients With Advanced Cancers

NCT02459067 | Terminated Phase 2

• 1 other identifier: TCB-101-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Malignant Melanoma; Non-small Cell Lung Cancer; Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

ImmuniCell®

EXPERIMENTAL

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.

Biological: ImmuniCell®

Interventions

ImmuniCell® BIOLOGICAL

Autologous γδ T Lymphocytes

ImmuniCell®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥18 years
• Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Subjects with histological or cytological confirmation of advanced malignant melanoma, renal cell carcinoma or NSCLC which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
• Measurable disease according to the irRC criteria
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted \<2 weeks prior to Cycle 1:
• Creatinine ≤ 1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 ml/min
• Total bilirubin ≤ 1.5 x ULN
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases
• Absolute lymphocyte count ≥1.0 x 10E9/L
• Absolute Neutrophil Count (ANC) ≥1.5 x 10E9/L
• Platelets ≥100 x 10E9/L
• Haemoglobin ≥ 10 g/dL
• Life expectancy of at least 3 months
• Suitable increase in starting γδ T cell number to final γδ T cell number in the proliferation assay between 10 days in culture
• Able to give informed, written consent

You may not qualify if:

• Other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 2 years ago without any evidence or recurrent disease
• Uncontrolled systemic infection
• Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency)
• Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months and throughout the trial
• New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months
• Clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy.
• Ulcerative Colitis / Inflammatory bowel disease, Addison's disease
• Pregnancy or lactation before or during the trial. A urine pregnancy test will be carried out at screening
• Taking any other investigational medicinal product (IMP) or participation in another interventional clinical trial in the previous 30 days
• Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin C and nitrosureas
• Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
• Serological evidence of active infection

Sponsors & Collaborators

• TC Biopharm: lead

Study Sites (7)

Velindre Cancer Centre and University Hospital of Wales

Cardiff, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

St. James's University Hospital

Leeds, United Kingdom

Location

University College London Hospital

London, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeff Evans, Prof.

  Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow G12 0YN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 1, 2015
• Study Start: December 1, 2015
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (7)