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Trial record 1 of 1 for:    ATX-MAP-001
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Prospective Tissue Collection Research Protocol

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ClinicalTrials.gov Identifier: NCT03517917
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : March 8, 2024
Sponsor:
Information provided by (Responsible Party):
Achilles Therapeutics UK Limited

Study Description
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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
Solid Tumor 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
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : August 6, 2025
Estimated Study Completion Date : August 31, 2025
Groups and Cohorts
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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 Name: Blood collection


Outcome Measures
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Primary Outcome Measures :
  1. Obtaining samples for research [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517917


Contacts
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Contact: Patient Supply Operations Achilles Therapeutics +44 (0)208 154 4600 info@achillestx.com

Locations
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Sponsors and Collaborators
Achilles Therapeutics UK Limited
Investigators
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Study Director: Medical Monitor, MD Achilles Therapeutics
More Information
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Responsible Party: Achilles Therapeutics UK Limited
ClinicalTrials.gov Identifier: NCT03517917    
Other Study ID Numbers: ATX-MAP-001
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No