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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms of thyroid and other endocrine glands
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This Phase I study is looking at the effects of giving a type of immunotherapy, called 1RG-CART, to patients with relapsed or refractory neuroblastoma. Immunotherapy means treatment that uses the body’s own immune system to attack cancer. 1RG-CART are made by taking immune cells (called T-cells) from the patient’s blood, modifying them in the laboratory (‘transduction’) and then giving them back to the patient. The T-cells have a new gene inserted into them, which hopefully enables them to identify and attack the cancer by recognising and binding to a marker called GD2.
The main aims of the study are to find out:
• If 1RG-CART can be made in the laboratory and given safely to patients.
• The side effects of 1RG-CART and how to treat them.
• If giving chemotherapy first helps the 1RG-CART to survive in the body and proliferate (grow in numbers).
• How well and for how long 1RG-CART survive inside the body.
• Whether 1RG-CART cause tumour shrinkage.
Up to 27 patients will be treated in the following groups:
• Group 1 - will receive 1RG-CART alone.
• Group 2 - will receive a chemotherapy drug (cyclophosphamide) for four days before receiving 1RG-CART.
• Group 3 - will receive two chemotherapy drugs (cyclophosphamide and fludarabine) before 1RG-CART. Fludarabine will be given for five days and cyclophosphamide for four days (the two drugs are given together after the first day of fludarabine alone).
• Group 4 - will receive a higher dose of 1RG-CART than Groups 1 to 3. Chemotherapy may or may not be given first, depending on results in the previous groups. Group 4 may not be needed if 1RG-CART survive well in the previous groups.
Additional patients will then be recruited to whichever group shows the best 1RG-CART survival.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Gene Therapy;Immunotherapy;
You can take part if:
You may not be able to take part if:
This study has a two part eligibility process. PART A - Exclusion criteria to have blood cells collected and 1RG-CART manufactured: Patients should not meet (or be anticipated to meet) any of the exclusion criteria for the main trial. PART B - Exclusion criteria for the main trial: 1. Patients who have received anti-GD2 antibody treatment within the previous 2 weeks (based on the half life of ch14.18 antibody being 1-3 days in children). 2. Patients for whom rituximab is contraindicated due to severe previous hypersensitivity or any other reason. 3. Patients must have recovered from the acute reversible effects of any previous therapy before infusion of the 1RGCART. 4. CNS involvement (including intradural meningeal involvement). 5. Co-existing chronic progressive neurological disease. 6. Airway compromise by direct tumoural invasion or compression. 7. Patients with active autoimmune disease requiring systemic treatment. 8. Patients who are taking or likely to require high dose systemic corticosteroids or other immunosuppressive therapy (patients on steroid replacement therapy are eligible). 9. Patients at high medical risk because of non-malignant systemic disease including active uncontrolled infection. 10. Major surgery from which the patient has not yet recovered. 11. Female patients who are able to become pregnant (or already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral; injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of the lymphodepleting regimen or at administration of the 1RG-CART (whichever comes first), throughout the trial and for six months afterwards are considered eligible. Note that for female patients who receive cyclophosphamide or rituximab, the contraceptive period should be extended to 12 months after cyclophosphamide/rituximab administration. 12. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] effective at the first administration of the lymphodepleting regimen or at administration of the 1RG-CART [whichever comes first], throughout the trial and for six months afterwards). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example: condom plus spermicidal gel) to prevent exposure to the foetus or neonate. 13. Known to be serologically positive for hepatitis B, hepatitis C or HIV. 14. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial. 15. Is a participant in another clinical trial of an investigational medicinal product (CTIMP). Participation in an observational trial or in the follow-up phase of a CTIMP would be acceptable.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by CANCER RESEARCH UK and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 20446
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