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Prospective Tissue Collection Research Protocol

Sponsor
Achilles Therapeutics UK Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03517917
Collaborator
(none)
400
Enrollment
18
Locations
90.7
Anticipated Duration (Months)
22.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective Collection of Donor Tissue and Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
Actual Study Start Date :
Feb 8, 2018
Anticipated Primary Completion Date :
Aug 6, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Obtaining samples for research [5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    6. White cell count ≥ 3 x 10^9/L

    7. Negative laboratory test for blood borne pathogens (see exclusion criterion).

    8. 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. For selected solid tumours additional exclusion criteria may apply.

    5. 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.

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

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

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

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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Achilles Investigator Site 19 New York New York United States 10065
    2 Achilles Investigator Site 14 Durham North Carolina United States 27710
    3 Achilles Investigator Site 24 Barcelona Spain
    4 Hospital Clinic Barcelona 26 Barcelona Spain
    5 Achilles Investigator Site 17 Madrid Spain
    6 Achilles Investigator Site 25 Madrid Spain
    7 Achilles Investigator site 01 London England United Kingdom
    8 Achilles Investigator site 02 London England United Kingdom
    9 Achilles Investigator site 12 London England United Kingdom
    10 Achilles Investigator site 13 London England United Kingdom
    11 Achilles Investigator site 29 London England United Kingdom
    12 Achilles Investigator site 03 Manchester England United Kingdom
    13 Achilles Investigator site 04 Newcastle England United Kingdom
    14 Achilles Investigator Site 22 Glasgow United Kingdom
    15 Achilles Investigator Site 11 Leeds United Kingdom
    16 Achilles Investigator Site 28 London United Kingdom
    17 Achilles Investigator Site 29 London United Kingdom
    18 Achilles Investigator Site 05 Southampton United Kingdom

    Sponsors and Collaborators

    • Achilles Therapeutics UK Limited

    Investigators

    • Study Director: Medical Monitor, MD, Achilles Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Achilles Therapeutics UK Limited
    ClinicalTrials.gov Identifier:
    NCT03517917
    Other Study ID Numbers:
    • ATX-MAP-001
    First Posted:
    May 8, 2018
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 17, 2022