Prospective Tissue Collection Research Protocol

  • STATUS
    Recruiting
  • End date
    Aug 31, 2025
  • participants needed
    300
  • sponsor
    Achilles Therapeutics UK Limited
Updated on 2 September 2021
cancer
breast cancer
lung cancer
metastasis
neutrophil count
blood transfusion
aptt

Summary

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

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.

Details
Condition Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour
Treatment Tumour tissue collection
Clinical Study IdentifierNCT03517917
SponsorAchilles Therapeutics UK Limited
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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
Additional criteria for patients undergoing leukapheresis to be tested within
Head and neck patients should have squamous cell carcinoma
days of leukapheresis as per standard local procedures
Renal cancer patients should have clear cell or papillary carcinoma
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
Pregnant or breast feeding women
Non Small Cell Cancer (NSCLC) patients with a known driver mutation in EGFR, ROS-1 or ALK
For selected solid tumours additional exclusion criteria may apply
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
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 with mucosal or acral melanoma
Patients who are currently participating in a clinical trial involving an unlicensed medical product
NSCLC and Head and neck cancer patients who have never smoked
Renal cancer patients with predominantly chromophobe or sarcomatoid tumours
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
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
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
Must not have any coagulopathy or platelet disorder
Must have no evidence of any skin infection at the time of the procedure
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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