Prospective Tissue Collection Research Protocol

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ClinicalTrials.gov Identifier: NCT03517917

Recruitment Status : Recruiting

First Posted : May 8, 2018

Last Update Posted : August 27, 2021

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Sponsor:

Information provided by (Responsible Party):

Achilles Therapeutics UK Limited

Study Description

Brief Summary:

This study aims to collect matched donor tissue and blood to enable the development of a manufacturing process for potential immunotherapies.

Condition or disease	Intervention/treatment
Solid Tumor	Other: Tumour tissue collection

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Detailed Description:

This study intends to collect blood and tumour samples from consenting patients for the development of manufacturing processes for potential immunotherapies.

Schedule 1:

Patients who do NOT consent to participate in a leukapheresis procedure will follow schedule 1 of the protocol.

Visit 1: Suitable patients will provide consent at the first patient visit, followed by baseline assessments as per standard of care and per protocol. Details will also be collected about current medical conditions and procedures and current medications. Patients will be tested for infectious diseases e.g. Human Immunodeficiency Virus (HIV), Human T-cell lymphotropic virus (HTLV), Hepatitis B, Hepatitis C and Syphilis.

Visit 2: Procured tumour samples will be obtained during the patients standard of care surgery, or the patient may provide a superficial skin or subcutaneous lymph node disease sample strictly for the purposes of the trial. All patients will also donate a whole blood sample conducted as a non-standard of care procedure.

All donated samples will be couriered to a specialist Sponsor laboratory with appropriate oversight maintained.

Visit 3: Following the surgical procedure patients will receive their standard follow up care. Under this protocol a follow up telephone call will be made to ensure patients have recovered fully.

Patients who DO consent to participate in a leukapheresis procedure will follow either schedule 2 OR schedule 3.

Schedule 2:

Visit 1: As described in schedule 1.

Visit 2: As described in schedule 1.

Visit 3 serves as a re-confirmation of eligibility (screening) to undergo leukapheresis collection.

Visit 4: The leukapheresis procedure is conducted, providing the patient consents and is deemed fit by their treating physician to undergo the procedure.

Visit 5: Safety follow up visit. Under this protocol a follow up telephone call will be made to ensure patients have recovered fully.

Schedule 3 (UK only):

Visit 1: As described in schedule 1.

Visit 2: The leukapheresis procedure is conducted, providing the patient consents and is deemed fit by their treating physician to undergo the procedure.

Visit 3: serves as a leukapheresis safety follow up and surgical screen.

Visit 4: Procured tumour samples will be obtained during the patients standard of care surgery, or the patient may provide a superficial skin or subcutaneous lymph node disease sample strictly for the purposes of the trial. All patients will also donate a whole blood sample conducted as a non-standard of care procedure.

All donated samples will be couriered to a specialist Sponsor laboratory with appropriate oversight maintained.

Visit 5: Safety follow up visit. Under this protocol a follow up telephone call will be made to ensure patients have recovered fully.

Study Design

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Study Type :	Observational
Estimated Enrollment :	300 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 :	February 8, 2018
Estimated Primary Completion Date :	August 6, 2025
Estimated Study Completion Date :	August 31, 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
Arm 1 Tumour tissue collection and blood 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

Primary Outcome Measures :

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 Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.

Eligibility Criteria

Information from the National Library of Medicine

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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:

Patient must be at least 18 years old at the Screening Visit.
Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.
Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.
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.
Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks.
White cell count ≥ 3 x 10^9/L
Negative laboratory test for blood borne pathogens (see exclusion criterion).
Non Small Cell Cancer (NSCLC) and Head and neck patients should be current or ex-smokers.
Head and neck patients should have squamous cell carcinoma.
Renal cancer patients should have clear cell or papillary carcinoma.

Additional criteria for patients undergoing leukapheresis to be tested within 14 days of leukapheresis as per standard local procedures:

Haematocrit (HCT)>38%.
Hb ≥ 10g/dL without transfusion support for at least 3 weeks.
White Blood Cells (WBC) ≥ 3.0 x 109/L.
Neutrophils ≥ 1.0 x 109/L.
Platelets ≥50 x 109/L.
No coagulopathy and PT and APTT < 1.5x ULN.
Albumen >20g/l.
AST or ALT ≤ 2.5x ULN.
Bilirubin < 1.5x ULN (< 3x ULN in Gilbert's Syndrome).
Creatinine clearance/estimated GFR ≥ 60 mL/min.
Blood Pressure ≥110/70mmHg and <160/100mmHg.
Weight >120lbs (8.5 stone/ 55 kg).

Patients must be deemed fit for procedure in accordance with local apheresis guidelines.

Exclusion Criteria:

Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.
Inadequate peripheral venous access precluding collection of blood. In some cases arterial access may be approved by the Sponsor if deemed clinically safe by the physician.
Pregnant or breast feeding women.
Patients with mucosal or acral melanoma.
Non Small Cell Cancer (NSCLC) patients with a known driver mutation in EGFR, ROS-1 or ALK.
NSCLC and Head and neck cancer patients who have never smoked.
Renal cancer patients with predominantly chromophobe or sarcomatoid tumours.
For selected solid tumours additional exclusion criteria may apply.
Known/laboratory confirmed diagnosis of an active infectious disease preventing inclusion of tissue into cell manufacturing suite.
As a minimum, the patient will undergo specific screening for the following infections, including as a minimum serology for Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis. Other tests may be performed per local site SOP's. If performed, any positive test results must be reported to the study sponsor.
Patients who are currently participating in a clinical trial involving an unlicensed medical product.
Patients who have received any anti-cancer therapy (including investigational products) within three weeks prior to tissue procurement. Any adjustment to this for exploratory material research purposes must be pre-approved by Sponsor.
Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
Any medical reason why, in the opinion of the investigator, the patient should not participate in this study.
Patients who elect to undergo leukapheresis:
1. Must not have received any chemotherapy within 3 weeks prior to the procedure. Any adjustment to this for exploratory material research purposes must be pre-approved by Sponsor.
2. Must not have any coagulopathy or platelet disorder.
3. Must have no evidence of any skin infection at the time of the procedure.

Contacts and Locations

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: Senior VP Clinical Operations Achilles Therapeutics, PhD	+44 (0)208 154 4600	info@achillestx.com

Locations

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United States, North Carolina
Achilles Investigator Site 14	Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeffrey Clarke, MD
Spain
Achilles Investigator Site 25	Recruiting
Madrid, Spain
Contact: Maria de Miguel, MD
United Kingdom
Achilles Investigator site 04	Recruiting
Glasgow, England, United Kingdom
Contact: Alistair Greystoke, MD
Achilles Investigator site 01	Recruiting
London, England, United Kingdom
Contact: Martin Forster, MD
Achilles Investigator site 02	Recruiting
London, England, United Kingdom
Contact: Samra Turajalic, MD
Achilles Investigator site 12	Recruiting
London, England, United Kingdom
Contact: Sheeba Irshad, MD
Achilles Investigator site 13	Recruiting
London, England, United Kingdom
Contact: Maxine Tran, MD
Achilles Investigator site 29	Recruiting
London, England, United Kingdom
Contact: Eric Lim, MD
Achilles Investigator site 03	Recruiting
Manchester, England, United Kingdom
Contact: Yvonne Summers, MD

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:	August 27, 2021
Last Verified:	August 2021
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

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