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RecruitingLast updated: 2 February 2024

Lewis Y Nivo-CAR-T: This phase I study is testing a new cancer treatment that targets the tumour marker Lewis Y ('Lewis Y Chimeric Antigen Receptor T-cell Therapy') in combination with a commonly used immunotherapy drug (nivolumab) in people with Lewis Y-expressing solid cancersA Pilot Study Assessing Safety and Tolerability of Lewis Y (LeY) targeting Chimeric Antigen Receptor (CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours

Clinical summary


All eligible participants will receive treatment with Lewis Y Chimeric Antigen Receptor T-Cell Therapy and nivolumab. Prior to treatment, participants will have blood collected to generate the T-cells required for treatment. Participants will then follow a chemotherapy regimen designed to reduce the number of the body's T-cells so that the newly generated T-cells can be administered. This will involve intravenous (IV) infusions of the drugs fludarabine and cyclophosphamide once per day for 3 consecutive days in the week prior to T-cell therapy. People enrolled in this study will be part of one of two groups: Dose Escalation or Dose Expansion. In the Dose Escalation phase, different dose levels of the cell therapy will be tested. Each participant will receive one dose only by IV infusion. The doses tested will be increased or decreased for additional participants enrolled until a safe dose is determined. This safe dose will then be used for the Dose Expansion phase. In Dose Expansion, participants may receive up to two doses of cells infused one hour apart by IV infusion. Nivolumab will be administered to all participants by IV infusion on the day prior to T-cell therapy, and on days 14, 28 and 42 after T-cell therapy.


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Trial Acronym

Lewis Y Nivo-CAR-T

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Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

A Pilot Study Assessing Safety and Tolerability of Lewis Y (LeY) targeting Chimeric Antigen Receptor (CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours



1. Patient has provided written confirmation of informed consent on participant information and consent form (PICF)
2. Patients with an advanced solid tumour (defined as incurable locally advanced or metastatic disease and excluding any haematologic malignancy) Patients who are eligible for PBS-reimbursed PD1 or PD-L1 inhibitors must have received this prior to study enrolment
3. Tumour is positive for LeY expression by immunohistochemistry (IHC) defined as a staining of greater than or equal to 10 % of tumour cells positive for LeY expression
4. Patient is at least 18 years of age at the time of consent
5. Patient has an ECOG performance status of 0-1
6. Life expectancy of greater or equal to 12 weeks
7. Patient has adequate organ function satisfying all of the following:
-Bilirubin less than or equal to 1.5x upper limit of normal (ULN) unless patient has known Gilbert’s syndrome, then less than or equal to 3x ULN
-AST/ALT less than or equal to2.5 x ULN except in patients with known liver metastases where AST/ALT less than or equal to 5.0 x ULN
-Serum creatinine less than 1.5x ULN or creatinine clearance greater than 50ml/min. Creatinine clearance is either derived using the Cockcroft-Gault formula or may be measured by 24 hour urine collection or nuclear medicine assessment
-Adequate pulmonary function defined by SaO2 greater than 91% on room air and less than or equal to grade I dyspnoea
-Left ventricular ejection fraction (LVEF) greater than or equal to 40% as confirmed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA)
-Absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^(9)/L
-Absolute lymphocyte count greater than or equal to 0.5 x 10^(9)/L
-Platelets greater than or equal to 100 x 10^(9)/L
-Haemoglobin greater than or equal to 80g/L
-White cell count (WCC) less than 30 x 10^(9)/L
8. Patient is deemed capable and willing to undergo the planned study procedures in the view of the Investigator
9. Patient has measurable disease as per RECIST 1.1
10. For patients undergoing the (64)^Cu SPION imaging:
a. Patient must pass institutional MRI safety questionnaire
b. Patient must not exceed physical limitations of scanner (weight greater than 105kg and/or height greater than 185cm)
c. Patient must feel they are able to tolerate proposed imaging sequences (e.g. Patient must not suffer from severe claustrophobia or other condition that would prevent them from undergoing MRI)
d. Patients must not have a known allergy to nickel or palladium
11. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
12. Female patients of childbearing potential must be willing to commit to either abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously. Where one of the methods is a highly effective method of contraception (failure rate of less than 1% per year when used consistently and correctly; see examples below) and one other effective method (i.e., male latex or synthetic condom, diaphragm, or cervical cap) and patient must agree to remain on both methods from the time of signing the patient information and consent form (PICF) until at least 1 year after receiving LeY CAR T cell therapy. Reliable contraception is indicated even where there has been a history of infertility, unless it is due to hysterectomy. Women of childbearing potential (WOCBP) should be referred to a qualified provider of contraceptive methods, if needed. Examples of highly effective contraceptives include:
-User-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone-releasing system; 3) vasectomised partner
-User-dependent method: progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable)
Woman of childbearing potential are those who have not been surgically sterilized or have not been free from menses related to menopause for greater than 1 year
13. Male patients must commit either to abstaining continuously from heterosexual intercourse or a man who is sexually active with a woman of childbearing potential or a pregnant woman must agree to use a barrier method of contraception from the time of
signing the PICF until at least 1 year after receiving LeY CAR T cell therapy, even if they have undergone a successful vasectomy


1. Patients with known active central nervous system (CNS), involvement by malignancy. [N.B. Patients with previously treated and/or neurologically stable disease (asymptomatic brain metastases not requiring steroid treatment) will be eligible]
2. Prior CAR T cell therapy
3. Patient has been given chemotherapy and/or granulocyte-colony stimulating factor (G-CSF) within 4 weeks of study registration or is planned to receive such therapy prior to apheresis of PBMC. Patients can only receive cytotoxic drugs as per the schedule of treatment for this protocol
4. Patient has had immunosuppressive therapy within 4 weeks of apheresis. Therapeutic doses of steroids (defined as greater than 10 mg/day of Prednisolone (or equivalent)) must be able to be stopped within 7 days prior to leukapheresis and 72 hours prior to LeY CAR T cell infusion. Physiologic doses of steroid (e.g. Prednisolone less than 10mg or equivalent), topical and inhaled steroids are permitted
5. Patients who are eligible for potentially curative therapy
6. Uncontrolled active or latent Hepatitis B (HBV) or active Hepatitis C (HCV) or HIV
7. Patients with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate treatment
8. A presence of active clinically relevant CNS pathology such as epilepsy, aphasia, severe brain injury, dementia, Parkinson’s disease, cerebellar disease or psychosis
9. Radiation therapy within 2 weeks prior to registration
10. Patient has an active other haematologic or solid malignancy with the exception of superficial BCC or SCC
11. Patient has a history of significant pulmonary disease (including radiation pneumonitis) or known, biopsy proven autoimmune inflammatory disease of the gastrointestinal tract
12. Unstable angina or myocardial infarct within 6 months prior to screening
13. Patient has known clinically significant autoimmune disease
14. Women who are pregnant or breastfeeding
15. Patient has a serious uncontrolled medical disorder, psychological or social factors that which would impair their ability to receive protocol therapy and follow up in the opinion of the investigator
16. Receipt of live attenuated vaccination within 30 days of registration
17. Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency
18. Have a history of allergy to study drug components, or a history of severe hypersensitivity reaction to any mAb


  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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