Prospective Tissue Collection Research Protocol

Solid Tumor Clinical Trial

Official title:

Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517917
• Other study ID #: ATX-MAP-001
• Status: Recruiting
• Start date: February 8, 2018
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Achilles Therapeutics UK Limited
• Contact: Patient Supply Operations Achilles Therapeutics
• Phone: +44 (0)208 154 4600
• Email: info[@]achillestx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.

Description:

During standard of care surgery tumour samples which are surplus to the requirements of the patients diagnostic/treatment pathway will be procured along with a matched whole blood and/or leukapheresis sample. In some instances patients may consent to provide a non-standard of care, non-invasive research biopsy.

Within 28-42 days following procurement of samples patients will be required to participate in a safety follow up call for assessment of any procedure related adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2025
• Est. primary completion date: August 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged = 18 years

2. Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.

3. Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.

4. Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.

5. Haemoglobin(Hb) = 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood).

6. White cell count = 3 x 10^9/L (for patients donating whole blood).

7. For selected solid tumours and leukapheresis procedure additional inclusion criteria apply.

Exclusion Criteria:

1. Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.

2. Inadequate peripheral venous access precluding collection of blood.

3. Pregnant or breastfeeding women.

4. Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis.

5. Patients who are currently participating in a clinical trial involving an unlicensed medical product.

6. Patients who have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement.

7. Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).

8. Any medical reason why, in the opinion of the investigator, the patient should not participate in this study.

9. For selected solid tumours and leukapheresis procedure additional exclusion criteria apply.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Other:
• Tumour tissue collection
Collection of tumour tissue and blood

Locations

Country	Name	City	State
Spain	Catalan Institute of Oncology - Institut Catala d'Oncologia	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	HM Sanchinarro University Hospital, START Madrid	Madrid
Spain	Instituto de Investigación Sanitaria Fundación Jimenez Díaz	Madrid
United Kingdom	NHS Greater Glasgow and Clyde (NHSGGC), Queen Elizabeth University Hospital	Glasgow	Scotland
United Kingdom	The Leeds Teaching Hospitals NHS Trust, St James's University Hospital	Leeds	England
United Kingdom	Guys and St Thomas' NHS Foundation Trust, Guy's Hospital	London	England
United Kingdom	Guys and St Thomas' NHS Foundation Trust, Royal Brompton Hospital	London	England
United Kingdom	Royal Free London NHS Foundation Trust, Royal Free Hospital	London	England
United Kingdom	The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital	London	England
United Kingdom	University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital	London	England
United Kingdom	Manchester University NHS Foundation Trust, Wythenshawe Hospital	Manchester	England
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital	Newcastle Upon Tyne	England
United Kingdom	University Hospital Southampton NHS Foundation Trust, Southampton General Hospital	Southampton	England
United Kingdom	Guys and St Thomas' NHS Foundation Trust, Harefield Hospital	Uxbridge	England
United States	Duke University Medical Centre	Durham	North Carolina
United States	Georgetown University Medical Center	Georgetown	Washington
United States	Memorial Sloan Kettering Cancer Centre	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Achilles Therapeutics UK Limited

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtaining samples for research	This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.	5 years