Prospective Tissue Collection Research Protocol

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Other: Tumour tissue collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Patient Supply Operations Achilles Therapeutics; Phone Number: +44 (0)208 154 4600; Email: info@achillestx.com

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08908
    • Completed
    • Catalan Institute of Oncology - Institut Catala d'Oncologia
  • Madrid, Spain, 28050
    • Recruiting
    • HM Sanchinarro University Hospital, START Madrid
  • Madrid, Spain, 28040
    • Completed
    • Instituto de Investigación Sanitaria Fundación Jimenez Díaz
• United Kingdom
  • England
    • Leeds, England, United Kingdom, LS9 7TF
      • Recruiting
      • The Leeds Teaching Hospitals NHS Trust, St James's University Hospital
    • London, England, United Kingdom, NW1 2PG
      • Recruiting
      • University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital
    • London, England, United Kingdom, SE1 9RT
      • Recruiting
      • Guys and St Thomas' NHS Foundation Trust, Guy's Hospital
    • London, England, United Kingdom, SW3 6JJ
      • Recruiting
      • The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital
    • London, England, United Kingdom, SW3 6NP
      • Recruiting
      • Guys and St Thomas' NHS Foundation Trust, Royal Brompton Hospital
    • London, England, United Kingdom, NW3 2QG
      • Completed
      • Royal Free London NHS Foundation Trust, Royal Free Hospital
    • Manchester, England, United Kingdom, M23 9LT
      • Recruiting
      • Manchester University NHS Foundation Trust, Wythenshawe Hospital
    • Newcastle Upon Tyne, England, United Kingdom, NE7 7DN
      • Recruiting
      • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
    • Southampton, England, United Kingdom, SO16 6YD
      • Completed
      • University Hospital Southampton NHS Foundation Trust, Southampton General Hospital
    • Uxbridge, England, United Kingdom, UB9 6JH
      • Recruiting
      • Guys and St Thomas' NHS Foundation Trust, Harefield Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Completed
      • NHS Greater Glasgow and Clyde (NHSGGC), Queen Elizabeth University Hospital
• United States
  • New York
    • New York, New York, United States, 10065
      • Completed
      • Memorial Sloan Kettering Cancer Centre
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Completed
      • Duke University Medical Centre
  • Washington
    • Georgetown, Washington, United States, 20057
      • Withdrawn
      • Georgetown University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with solid tumour scheduled for either biopsy or resection of their tumour(s) as part of their standard of care, and patients with superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed.	Other: Tumour tissue collection; Collection of tumour tissue and blood; Other Names: Blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Achilles Therapeutics UK Limited
• Investigators: Study Director: Medical Monitor, MD, Achilles Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Estimated): August 6, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ATX-MAP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No