LeYPh1-02 : A phase I study investigating the safety and tolerability of an infusion of T lymphocytes transduced with an anti-Lewis Y (LeY) chimeric receptor gene in patients with LeY expressing solid tumours

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer

Systemic therapy | Bowel (colorectum),Brain and spinal cord,Breast,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAnus,Astrocytoma,Basal cell carcinoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Lung,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva

Trial Overview Read MoreRead more

This phase I trial is assessing a new systemic therapy (LeY CAR-T cell therapy) in patients with solid cancers that express the LeY gene.

This trial is treating patients with solid cancers that express the LeY gene (excluding blood cancer).

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A phase I study investigating the safety and tolerability of an infusion of T lymphocytes transduced with an anti-Lewis Y (LeY) chimeric receptor gene in patients with LeY expressing solid tumours

Commercial Sponsor

Johnson & Johnson Pharmaceutical Research & Development


This study will test the safety, tolerability and effectiveness of an experimental treatment called “LeY CAR-T cell therapy”in treating solid tumours that carry the Lewis Y marker. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an advanced solid tumour that is positive for the Lewis Y antigen. Study details The Lewis Y antigen is a molecule that coats the surface of a cancer cell and is not usually detected by T-cells. The “LeY CAR-T cell therapy” may help the T-cells to find and destroy the cancer cells more easily. In this study, the T-cells will first be collected using a procedure called “Apheresis” that takes part before the study treatment. Apheresis collects some of the white blood cells (also called Leukocytes) including T-Cells from the blood. The collected T-cells will then be modified in the laboratory by a viral vector, to specifically target the cancer cells that have the Lewis Y marker on their surface. After T-cells have been modified, the viral vector will be separated from modified T-cells and removed. Modified T-cells can now be called CAR-T cells. The finished LeY CAR-T cells will then be infused back into the body, without the viral vector. As well as the LeY CAR-T cell therapy, patients will receive by lymphodepleting conditioning chemotherapy as intravenous fludarabine for 2 consecutive days prior to cell infusion to increase immunosuppression and improve persistence of engineered T-cells. LeY CAR-T cell therapy is an experimental treatment. This means that it is not an approved treatment for LeY expressing solid tumours in Australia.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Enquiries Line Coordinator
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.