Major thoracic or abdominal surgery from which the patient has not yet recovered. 7. At high medical risk because of non- malignant systemic disease including active uncontrolled infection. 8. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). 9. Evidence of any ongoing active autoimmune disease. 10. Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), prior history of cardiac ischaemia or prior history of cardiac arrhythmia. 11. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I trial of AST -VAC2. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable. 12. Any vaccination given within four weeks before the first AST -VAC2 vaccination (except for COVID -19 vaccinations, which are permitted at the Investigator’s discretion) . 13. Any planned prophylactic vaccination from trial entry until completion of the AST-VAC2 vaccinations (except for planned COVID -19 vaccinations, which are permitted at the Investigator’s discretion) . 14. Any condition which might interfere with the patient’s ability to generate an immune response. 15. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial. * Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post -ovulation methods) and withdrawal are not acceptable methods of contraception. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 27 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK 4.2 Patient enrolment Before enrolling the patient in the trial, the Investigator or designated representative should determine the eligibility of the patient during the trial screening period. Please ensure that th e Sponsor is notified of any eligibility concerns at least four working days before treatment is planned. Eligible patients must be enrolled in the electronic data capture ( EDC ) system by site staff and then registered by the Sponsor before they start treatment with AST-VAC2 . Eligible patients will be allocated a trial number by the EDC system during the enrolment process. The Sponsor will send confirmation of the patient registration and dose level , to the investigator following enrolment of the patient ; trial treatment may only be administered after this confirmation has been received. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 28 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK 5 TREATMENT 5.1 Selection of the Phase I clinical dose and schedule The therapeutic vaccine will be administered via two intradermal ( id) injections at a target dose of 1x 107 cells on each vaccination day. The actual cell dose patients may receive will vary , up to a maximum of 2 x107 viable cells, to achieve a target dose of 1 x 107 viable cells – Section 6.2.5 for further details on dose. The dose of AST -VAC2 has been selected based on previous clinical experience with autologous dendritic cells ( DCs) in which a dose of 1x107 cells was shown to induce anti -hTERT T cell responses in patients with either prostate cancer or AML. 5.2 Dosing schedule/treatment schedule Patients will receive six AST-VAC2 vaccinations, administered by i d injection weekly over a period of six weeks. An interval of 7 days (+/ -1 day) should occur between each of the vaccination days. The target total administered dose of vaccine is 1x107 cells of AST -VAC2 which will be administered as t wo id injections for each vaccination. AST-VAC2 vaccine will be given by id injection in the deltoid muscle of the arm, the outer thigh surface, anterior abdominal wall or buttock . If an injection site reaction (ISR) has resolved after the first vaccination /previous vaccination days then for subsequent injections , injections can be administered at the same body site. If an ISR from a previous vaccination is still present ( >Grade 1) then the injections should be administered into an alternative site . Only one dose of AST -VAC2 will be explored in this trial. A reduced dose/administration schedule may be considered as per Section 3.3 based on emerging safety data. 5.3 Enrolment Initially, one patient will be recruited and will receive their first four vaccinations before the second and third patients are recruited. It is acceptable for these next patients to receive treatment in parallel. The second and third patients must receive their first four vaccinations before recruitment is opened to the remaining patients . Safety evaluations by the Sponsor and collaborating Investigators (Section 3.3 ) will be conducted after the first patient has received AST -VAC2 and then again after the second and third patients have been treated . Once open recruitment has been initiated, safety review will be performed at regular intervals (as required) . 5.3.1 Dose reductions Pending discussions between the Sponsor and Chief Investigator ( CI) and based on vaccine availability, the following options may be c onsidered during the trial : • Reduced dose and/or • Modified number of vaccinations, e.g. if plateaued immune responses are observed with fewer vaccinations in those patients already treated. 5.3.2 Dose delays & interruptions If at the time of the next scheduled vac cination day, one or more adverse events ( AEs) (excluding ISRs) related to the AST-VAC2 vaccine (highly probably, probably or possibly related) are still present , have not resolved to Grade ≤1 and are considered by the Investigator to be clinically significant and a clear contraindication to vaccination, the next vaccination day should be delayed for up to two weeks until the AE(s) have recovered to this level. In case of uncertainty, individual cases should be discussed with the Sponsor. Patients who require a dose interruption of greater than two weeks will be reviewed on a case by case basis to determine whether the patient should be withdrawn from the trial. The Sponsor will confirm whether an extended interruption is acceptable or if the patient should be withdrawn from further trial treatment. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 29 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK If the patient is administered a COVID -19 vaccination during the AST -VAC2 vaccination period, there should be a 48 hours interval between the two vaccinations and they should be administered to different sites. The AST -VAC2 vaccination should be delayed as needed to accommodate this interval. If the patient is withdrawn from further trial treatment, follow up information and post vaccination research blood sampling will still be applicable unless the patient withdraws consent from further follow up and participation in the trial or if the Sponsor advises that further sampling is not required. 5.4 Duration of treatment Treatment should continue so that the patient receives six vaccinations unless (a) the patient asks to be withdrawn, (b) there is evidence of disease progression (as per Immune- Related Response Criteria (irRC) given in Appendix 3 ), (c) the patient is experiencing unacceptable toxicity or (d) the investigator feels the patient should stop the vaccinations for any other reason. Other reasons are listed in Section 11.0 . An End of Vaccination visit will be carried out 30 days post the last vaccination day. This visit will document any emerging AEs since the last vaccination. Adverse events present at this visit, attributed to AST -VAC2 (highly probably, probably or possibly related) will be followed up until resolution or stabilisation of these events (even if the patient starts another anti- tumour treatment ). If a patient terminates treatment prematurely, an E nd of Vaccination visit should be performed within 30 days of the last vaccination day or when the decision is taken to withdraw the patient from further vaccinations or the trial. These patients should also be asked to continue attending hospital for the 3, 6 and 12 month from first vaccination follow -up visit s to provide blood samples for immune analysis (unless the patient withdraws consent from further follow up and participation in the trial or if the Sponsor advises that further sampling is not required). Patients will be asked to attend follow up as per Se ction 7.4 until the end of trial ( EoT) is declared . The ‘End of Trial’ will be declared when all patients have either withdrawn (see Section 11.0 ) from the trial or died, or the last patient has completed thei r final follow -up visit (5 years post the first vaccination), whichever is the latter. 5.4.1 Replacement of patients Three administrations of AST -VAC1 (i.e. three complete doses) have previously been shown to demonstrate the first indications of an immune response therefore patients who receive fewer than three AST-VAC2 vaccinations (for reasons other than toxicity) will be replaced, pending vaccine availability . 5.5 Concomitant medication and treatment Concomitant medication may be given as medically indicated. Details (including name , indication for use and start and stop dates ) of the concomitant medication given must be recorded in the patient’s medical records and details entered into the eCRF. The patient must not receive other anti -cancer therapy or investigational drugs during the v accination phase of the trial . Following the vaccination period, if other treatment is received during the follow up period, this should be documented accordingly however , follow up information (including AEs related to AST-VAC2 ) should still be collected as per protocol, Section 7.4. Use of immunosuppressive medication, including corticosteroids (other than replacement dosing for adrenal insufficiency/pituitary failure), is excluded in this protocol. Inhaled and topical steroids are permitted. A short course of systemic steroids may be permitted for management of adverse events, however, this should be discussed and agreed in advance by the CDD Medical Advisor and/or the Chief Investigator . Patients may be administered a COVID -19 vaccine during the trial (including during screening), at the discretion of the Investigator. Where possible, the CO VID-19 vaccination should be administered before CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 30 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK trial entry or after completion of the AST -VAC2 vaccination period. However, if the COVID -19 vaccination is to be administered during the AST -VAC2 vaccination period, there should be an interval of 48 hours between administration of the two vaccines and they should be administered to different sites. Details of the COVID -19 vaccination should be recorded in the medical records and details entered in the eCRF. CONFIDENTIAL CRUKD/17/003 Protocol Final 5.0 dated 08Jun2021 Page 32 of 72 EudraCT number : 2016 -002577 -35 Cancer Research UK The product is supplied in Crystal Zenith (C Z) vials packed into a CZ box containing six individual doses and must not be removed from the primary packaging until time of administration. It must not be placed in any other container. Labelli ng requirements for the AST -VAC2 must include the following information: • Cancer Research UK , • AST-VAC2, • Batch XXX.XX.XX, • For Intra-Dermal admin, • Protocol No CRUKD/17/003 , • 0.6 mL at 2.0 x 107 cells/vial Expiry date will not be detailed on the vial but will be shown on the secondary packaging ( CZ boxes ). The actual cell dose patients may receive will vary , up to a maximum of 2 x107 viable cells, to achieve a target dose of 1 x 107 viable cells - please see Section 6.2.5. 6.2.5 AST-VAC2 administration Before administering the AST -VAC2 vaccine, the exact dosage must always be double- checked by a second suitably qualified person at site. All checks and double- checks must be documented (signed and da ted) and the documentation must be available for the CRA/CSM to verify. Each weekly AST -VAC2 vaccine dose will be administered as a split dose via two id injections at a target dose defined as 1 × 107 viable cells. Each vial of AST -VAC2 will be filled at a concentration of 2 x 107 viable cells per vial (pre -cryopreservation) and the release specification for the product strength has been set at > 1 x 107 viable cells/vial post thawing (based on stability data). The actual cell dose patients may receive will vary , up to a maximum of 2 x107 viable cells, to achieve a target dose of 1 x 107 viable cells. There is no dose escalation planned during CRUKD/17/003. Each vial of AST -VAC2 will contain 0.6 mL. For each vaccination, vial contents should be drawn into one needle from the vial and delivered as two separate id injections. Each injection will be a maximum of 0.3 mL each. The injections should be administered to the same body site approximately 1 cm apart. Patients should receive the id injections in either the deltoid muscle on the arm, the outer thigh surface, anterior abdominal wall or buttock . If an injection site reaction (ISR) has resolved after the first vaccination day/previous vaccination days then for subsequent injections , injections can be admini stered at the same body site. If an ISR from a previous vaccination is still present ( >Grade 1) then the injection should be administered into an alternative site . The site of injection will be documented for each vaccination. If a patient is administered a COVID -19 vaccination during the AST -VAC2 vaccination period, there should be an interval of 48 hours between the administration of the vaccines and they should be administered to different sites. 6.2.6 Vein extravasation/accidental spillages As AST-VAC2 is administered intradermally, vein extravasation should not be a potential risk. Accidental spillages should be dealt with according to hospital policy. 6.3 AST-VAC2 accountability Accurate records of all AST -VAC2 shipments and vials dispensed must be maintained in the local pharmacy. Once the product is thawed the injection must be administered within two hours. If this cannot occur, the product cannot be re- frozen and must be disposed of as per hospital policy . This must be noted on the inventory for authorisation by CRA/ CSM.