Prospective Tissue Collection Research Protocol

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

Tracking Information

• First Submitted Date: April 25, 2018
• First Posted Date: May 8, 2018
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: February 8, 2018
• Estimated Primary Completion Date: August 6, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2022)

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.

Original Primary Outcome Measures (submitted: April 25, 2018)

Obtaining samples for research [ Time Frame: 5 years ]

This protocol does not have an analysis primary outcome measure but rather will be conducted in accordance with GCP, solely for the purpose of obtaining samples for research.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Tissue Collection Research Protocol
• 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)
• 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.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Solid Tumor

Intervention

Other: Tumour tissue collection

Collection of tumour tissue and blood

Other Name: Blood collection

Study Groups/Cohorts

Arm 1

Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed.

Intervention: Other: Tumour tissue collection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 11, 2022): 400
• Original Estimated Enrollment (submitted: April 25, 2018): 500
• Estimated Study Completion Date: August 31, 2025
• Estimated Primary Completion Date: August 6, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03517917
• Other Study ID Numbers: ATX-MAP-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Achilles Therapeutics UK Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Achilles Therapeutics UK Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor, MD; Achilles Therapeutics

• PRS Account: Achilles Therapeutics UK Limited
• Verification Date: March 2024