Solid Tumor Clinical Trial
Official title:
Prospective Collection Tissue Research Protocol
This study aims to collect matched donor tissue and blood to enable the development of a manufacturing process for potential immunotherapies.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient must be at least 18 years old at the Screening Visit. 2. Patient has given informed consent to participate in the study 3. Suspected or confirmed diagnosis of solid tumour with either primary, recurrent or metastatic disease scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy. 4. Haemoglobin = 10g/dL 5. White cell count = 3 x 109/L 6. Negative laboratory test for blood borne pathogens (see exclusion criterion 5) Exclusion Criteria: 1. The patient is an employee of Achilles Therapeutics 2. Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue 3. Inadequate peripheral venous access precluding collection of blood 4. Known pregnancy 5. Known/laboratory confirmed diagnosis of an infectious disease preventing inclusion of tissue into cell manufacturing suite. As a minimum, the patient will undergo specific screening for the following infections: HIV 1 and 2, HTLV I/II, Hepatitis B, Hepatitis C, Syphilis. 6. Patients who are currently participating in a clinical trial involving an unlicensed medical product 7. Any medical reason why, in the opinion of the investigator, the patient should not participate in this study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Achilles Therapeutics Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Obtaining samples for research | This protocol does not have an analysis primary outcome measure but rather will be conducted in accordance with GCP for human research, solely for the purpose of obtaining samples for research. | 5 years |
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