Advanced, malignant melanoma, non-small cell lung cancer and renal cell carcinoma. MedDRA version: 20.0 Level: PT Classification code 10025650 Term: Malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classificatio
Conditions
Interventions
Product Name: ImmuniCell®
Product Code: TCB-101
Pharmaceutical Form: Infusion
INN or Proposed INN: ?d T lymphocytes
Current Sponsor code: TCB-101
Other descriptive name: ImmuniCell®
Concentration unit
Sponsors
TC BioPharm Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =18 years 2. Performance status ECOG 0 or 1 (Appendix 1) 3. 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 4. Measurable disease according to the irRC criteria 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1. 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 2. Uncontrolled systemic infection 3. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency) 4. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months or throughout the trial 5. New York Heart Association (NYHA) functional class =3 (Appendix 4) or myocardial infarction within 6 months 6. Clinically significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy 7. Ulcerative Colitis / Inflammatory bowel disease, Addison’s disease 8. Pregnancy or lactation prior to or during the trial. A urine pregnancy test will be carried out at screening 9. Taking any other IMP or participation in another interventional clinical trial in the previous 30 days 10. Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and more than 6 weeks since mitomycin C and nitrosureas 11. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results 12. Any other condition considered by a trial physician to be inappropriate for inclusion to the study such as contraindications to leukapheresis (contraindications to heparin which are: recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of Type II heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder) 13. Serological evidence of active infection with HIV, hepatitis B/C, HTLV and syphilis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial is an accelerated design in three stages, each stage having a different principal objective: Stage 1: The first stage of the study aims to identify a safe dose of ImmuniCell® to use in Stage 2 of the study. Stage 2: The principal objective of this stage of the study is to identify one or more tumour types which respond to treatment with ImmuniCell® according to pre-set rules and to look at the safety of ImmuniCell® treatment. Subjects with either skin cancer (malignant melanoma), lung cancer (non-small cell lung cancer) or kidney cancer (renal cell carcinoma) will participate in the study. Stage 3: This stage of the study will confirm, in a larger number of subjects, that ImmuniCell® is effective and safe in the cancer which had the highest response to treatment in the second stage of the study. This stage will be subject to a protocol amendment. ;Secondary Objective: The secondary objectives of the study are: To study the efficacy of ImmuniCell® treatment. To determine if ImmuniCell® treatment stimulates the immune system to mount an immune response with the potential to reduce the size of tumours. To try to identify a blood chemical which may give an indication that ImmuniCell® treatment is working (a biological response marker). This marker could be used in the future to judge if the treatment is working before scans are done to look for tumour reductions.;Primary end point(s): Stage 1 • 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) • Number, type and severity of toxicities and their relationship to treatment Stage 2 Tumour response (immediate or delayed CR, PR, SD or PD) by irRC Number, type and severity of toxicities and their relationship to treatment Stage 3 To be decided on evaluation of Stage 2 by DRC. A protocol amendment will b | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Stage 1 • Changes markers of immune response (such as IFN-?, IL-2 and TNF-a) before the first and subsequent ImmuniCell® infusions • Changes in peripheral T lymphocyte counts before the first and subsequent ImmuniCell® infusions (optional) Stage 2 • Efficacy of ImmuniCell® • Demonstrate the immune effect resulting from ImmuniCell® treatment • Persistence of ?d T cells in the peripheral blood (optional) Stage 3 The secondary outcome measures for this stage of the study will be decided on completion of Stage 2. ;Timepoint(s) of evaluation of this end point: Stage 2 Tumour response, PFS and overall survival will be evaluated at: 6, 12, 18, 24 36 and 48 weeks after baseline. Adverse events and safety blood assessments will be done at each visit. Immune response and microRNA analyses will be done at: Baseline, then 2, 4, 6, 8, 10 and 12 weeks after baseline. Stage 3 The timepoints for evaluations will be determined after Stage 2 when the study design can be formulated. | — |
Countries
Belgium, Canada, Czech Republic, France, Germany, Hungary, Italy, Netherlands, United Kingdom, United States
Contacts
Public ContactVP Clinical
TC BioPharm
Outcome results
None listed