• Cancer patients with solid tumors and hematologic malignancies
• Cancer patients staged at minimum of grade 2B
• Patients for whom all other options have been exhausted as long as the disease is stable, and the patient is not on any chemotherapy or radiation therapy concurrently.

• Cancer patients with CNS cancer
• Cancer patients < 18 years old
• Patients under Gamma Delta T Cell Therapy (GDTC)
• Patients under treatment with Radioactive Seeds
• Patients with Active Autoimmune Disease (ie Lupus, RA, Hashimoto's, Crohns, etc or clear indicator such as a high CRP and at least one positive autoimmune marker)

• Pregnancy or breastfeeding
• Recent blood transfusion – must wait 120 days
• Recent cytotoxic chemotherapy and/or radiotherapy – must wait 21 days
• Children under the age of 18 years old
• Immune Suppression Medication – the patient must wait at least 14 days
• Cachexia
• Active infections – (includes active Lyme and coinfections)
  • Indicators:
    • WBC >10,000
    • Lymph > 20%
    • CRP >5.0
    • ANC <500 (indicator of immune insufficiency)
    • NLR - high neutrophil to lymphocyte ratio of 3-1 or higher
• High inflammation:
  • Indicators:
    • CRP>5.0
    • Sed Rate >20 mm
    • AGP- a1-acid glycoprotein >110
    • Hemoglobin <8.5
• Tregs (CD25 + CTLA4) are present on the pre-Immune Frame (should be under 5%)
• High TNF-a on the pre–Immune Frame (should be under 5%)

• The patient must be off ALL cytotoxic and free radical producing therapies. If drawing for cellular therapies, the patient must be off ALL immunosuppressive therapies as well.
  • Blood Transfusions: at least 120 days
  • CDK Inhibitors: for at least 14 days
  • Chelation Therapy (IV): Avoid at least 14 days
  • Chemotherapy (non-platinum derivative): at least 14 days
  • Chemotherapy (platinum derivative): at least 21 days
  • Cryoablation: at least 7 days
  • Fever: at least 14 days
  • Gamma Delta T Cell Therapy (GDTC): Patients are not eligible for therapies due to the potential interaction with RGCC therapies.
  • Hormone suppression: at least 14 days (½ life x 7 is ideal formula for avoidance)
  • Hyperbaric Therapy: at least 7 days
  • Hyperthermia (generalized/systemic): no waiting
  • Hyperthermia (local/concentrated/microwave ablation): at least 30 days due to increased cellular debris released into the bloodstream
  • Immune Suppression Medication: (All pre-Cellular Therapies – Clavic-Q-RE, Vaccine Prep, Dendritic Cells, DendroCov): at least 14 days
  • Methylene Blue: at least 14 days
  • Mistletoe: Avoid for at least 14 days (can beneficial after therapy administration)
  • MOAB or SMW drugs: for at least 14 days
  • Natural Substances (IV): cytotoxic substances like Vitamin C or Ozone at least 14 days
  • Natural Substances (oral supplements): Class 1 or 3 cytotoxic substances (per patient’s Onconomics Plus results) at least 14 days.
  • NK1 Inhibitors: for at least 14 days
  • NSAIDS: Do not have to be discontinued
  • Off Label Medications: Ivermectin-FenBen-Itraconazole 14 days
  • Off Label medication: Doxycycline: 7 days
  • Off Label Medication: Metformin: 21 days
  • PEMF Therapy: at least 7 days
  • Plasmapheresis: Potential risk but not studied. Use your own discretion.
  • Radiation: at least 14 days
  • Radioactive Seeds: Patients are not eligible for therapies due to the prolonged and undetermined time of the radiation exposure
  • Scans with Contrast: at least 14 days
  • Surgery (brain or extensive): minimum of 30 days based on time of recovery. Could be longer if slow recovery or if the person had some type of adverse reaction. Must be evaluated on a case-by-case basis.
  • Surgery (simple/routine): at least 7-10 days

• Immune Frame (initial/baseline immune status) - not included in
  package
• Oncotrace (Baseline CTC) – not included in package
• It is highly recommended to evaluate the baseline Oncotrace and the initial Immune Frame prior to ordering the therapy to verify the patient’s eligibility. 30 ml of blood (1 vial) is sufficient for both tests if ordered at the same time.

• Checkpoint inhibitors (can be beneficial)
• Mild Hyperthermia (Infrared Sauna)
• Q-REstrain therapy (can be beneficial if given at least 14 days prior)

• Initial Immune Frame (Baseline test) (Draw 15 ml of blood)
• Oncotrace (initial CTC – baseline test) (Draw 15 ml of blood)
• Dose 1, 2 and 3 of Clavic-Q-RE (Draw 120-140 ml of blood)
• Follow up Immune Frame (Draw 15 ml of blood)
• Follow up Oncotrace (Draw 15 ml of blood)
• If ordering the Oncotrace, Immune Frame and all the three doses of the therapy at the same time then 150 ml of blood (5 vials) will be sufficient.
• Booster Dose (Draw 120-140 ml of blood)

• Package Includes:
  • All three doses of the Clavic-Q-RE Therapy
  • *One booster dose, when necessary
  • 2 Follow up Immune Frames – Day 120 and Day 210*
  • 2 Follow up Oncotrace Tests – Day 120 and Day 210*
• Whether a booster is administered, then the follow up of Day 210, is not performed and indeed, a follow up 90-days post booster administration is offered in the package
• Package DOES NOT include:
  • Initial (baseline) Immune Frame and Oncotrace tests
  • Additional follow up Immune Frames (past the Day 120 and Day 210 ones)

• Timeline is: one dose every two weeks for three total doses and two
  sets of follow up tests:
  • Pre-tests are drawn and ordered: (Oncotrace and Immune Frame)
  • Therapy is ordered and blood is drawn: (The time frame from initial order to receipt of the therapy is approx. 21 days)
  • Day 0 – 1st dose administered (Macrophages and NK cells)
  • Day 15 – 2nd dose administered (APCs, CTLs and plasma cells) - 2 weeks after Dose 1
  • Day 30 – 3rd dose administered (APCs, CTLs and plasma cells or Macrophages and NK cells or a mixture of what the patient needs as determined by RGCC)
  • Day 120 – Mandatory Follow up Immune Frame and Oncotrace - Included in package
  • Day 210 – Mandatory Follow up Immune Frame and Oncotrace - Included in package
  • * On Day 120 Follow Up evaluation-Whether the results are not appropriate, blood draw is required for the booster dose. In this case a new blood draw is required and the last follow up (Immune Frame and Oncotrace) which is Included in package is performed 90 days after the booster dose administration. In this case, no Day 210 follow up is offered in the package.
    
• It is recommended to follow the recommended administration schedule to ensure that the patient receives the highest viability/effect.
• Both doctors and patients need to schedule the administration of all three doses in advance to receive dose one (1) in order to avoid any delays with the additional two doses that will be upcoming.
• Should there be an unexpected delay, the therapy can be requested to be shipped and administered up to several weeks later without loss of efficacy. Be sure to ask the lab if this is the case with your particular patient. If the therapy has already shipped this option is no longer available.
• If the administration schedule was altered at all, then the follow up tests at day 120* are calculated at 90 days after Dose three (3) and then another 90 days after that for day 210* follow up tests.
• If a booster is given based on day 120 results, the day 210 follow up tests will move to 90 days post booster administration. All additional follow ups will be paid for out of pocket.

• Upon receipt of the vial, you will need to cross reference the number on the container to your patient’s name. There will not be a name on the actual therapy container, so this is important.
• Upon receipt of the therapy do your QC inspection. The cells are suspended in solution and are ready for administration. The solution should be colorless without any sign of precipitation.
• If not infused immediately, then place in the refrigerator (do not freeze).
  In case of any color changes or any precipitation DO NOT ADMINISTER. Immediately notify tour local branch/distributor.
• When ready to infuse, take the patient’s Clavic-Q-RE therapy vial out of the refrigerator and allow it to come up to ambient room temperature while the premeds are being given.

PRE-MEDS: Administer pre-medications prior to each dose of the
THERAPY.

• Mandatory: 4 mg dexamethasone I.V. in a 20-50 ml rapid drip saline solution or slow bolus push. For Doses 2 and 3 only. Do not use with Dose 1.
  • Optional but highly recommended: IV H2 inhibitors: (Famotidine, Cimetidine, Nizatidine) – given at least 60 min before IV. The reason for the H2 blocker is to decrease any chance of headache, nausea, vomiting, and diarrhea. This is rare but very unsettling if it happens.
  • Optional: Paracetamol (Acetaminophen), PO 500 mg, three times per day for three days (start an hour before the application) in order to counteract the headache that could develop.

• DO NOT administer pre-meds – it can compromise immune reaction
• Prepare 250-500 ml IV saline bag
• Remove the security tape carefully, remove cap, wipe the stopper with a sterile alcohol swab.
• Leave the bottle in an upright position to remove the sample, REASON: (the inside rims on rubber seal can sometimes cause cells to stick)
• Use a 10 ml syringe with a 21-gauge 2-inch needle and very slowly remove the 6ml of cells
• Administer the cells via a slow IV push. Remember to be slow and gentle
• Immediately following the IV push start the 250-500 ml saline bag over a 30–60-minute rapid drip
• This drip should not cause any pain or discomfort to the patient. In some cases, during the IV or shortly thereafter, the patient may begin to experience a slight fever, slight headache, or chills. This is generally a good thing but monitor the patient while in your office and instruct them to call you if the fever rises over 39 C degrees over the next several days.

• Start with a 250 – 500 ml bag of saline
• Start the IV line with Catheter to the patient
• You can give the IV form of any H2 inhibitors: Cimetidine, Nizatidine, or Famotidine-give at least 45-60 minutes before the IV. If giving the medications orally, it needs to be given 6 hours before the IV.
• Ready 4 mg dexamethasone I.V. in a 20-50 ml rapid drip saline solution or very slow bolus push
• Paracetamol (Acetaminophen), PO 500 mg starting an hour before administration and up to three times per day for up to three days after administration to help counteract the headache that could develop.
• Use a 10 ml syringe with a 21-gauge 2-inch needle and very slowly remove the 6ml of cells
• Administer the cells via a slow IV push. Remember to be slow and gentle
• Immediately following the IV push start the 250-500 ml saline bag over a 30–60-minute rapid drip

• Flu-like symptoms
• Fatigue
• Fever
• Injection site reaction (skin rash)
• Urticaria (hives)
• Tumor Lysis Syndrome (TLS) with large volume of tumors or in highly vasculated tumors (ie lung)
• Pain, swelling and inflammation at tumor site

• In order to allow the memory cells to fully develop it is best that patients stay off ALL cytotoxic, or free radical producing, and immunosuppressive therapies 120 days after the administration of the therapy.
• If 120 days is not possible due to advanced state of disease, the patient is able to resume:
  • IV Vitamin C after 7 days
  • Mistletoe after 14 days
  • PEMF after 7 days
  • Rife after 7 days
  • Hyperbaric Oxygen Therapy after 14 days
  • Ozone after 14 days
  • **Other treatments or therapies after 21 days including cytotoxic therapies and off label medications
• Note: Other substances must be evaluated on their half-life. The formula is ½ life span x 7 to determine the time required to be off the substance.

• Checkpoint inhibitors (can be beneficial)
• Mild Hyperthermia (Infrared Sauna)
• Q-REstrain therapy (can be beneficial if given at least 14 days prior)

• Mandatory Follow up Testing: Day 120 (90 days from Dose 3)
• Mandatory Follow up Testing Day 210 (180 days from Dose 3 or 90 days from Day 120 testing or 90 days from Booster dose)
• Immune Frame for verification of immune response
• Oncotrace for the follow up cell (CTC) count
• It is highly recommended to run a follow-up Immune Frame test every 6 months for at least 2 years to monitor CD80, CD86 and CD28 levels to determine if a booster becomes necessary. These tests are optional and not included in the original therapy package.
  • The Day 120 and Day 210* ( or post booster follow up) follow up tests are not ordered in the doctor’s portal
  • These are ordered via a “letterhead order”
  • Simply write on your clinic’s letterhead the patient's name and that you are ordering the Oncotrace and Immune Frame for the specific follow up (ie; Clavic-Q-RE Therapy - Day 120)
  • Include the letterhead order with the patient’s blood sample.

• Overall, preliminary results based on statistical analysis of CTCs and immune status, as well as on clinical evaluation and Karnofsky Index, indicate that there is an up-regulation of immunity. According to the ELISA analysis the activation of the humoral immunity is based on overproduction of relevant factors like CD80 and CD86.
• Sample Day 120 – Expected results:
  • T&B cells should be steadily present
  • CD 80 should be over 10%
  • CD 86 should be over 10%
  • CD 28 – B & T line should be above 0 (even barely is ok)
  • If memory cells are not well established on Day 120 then a booster should be administered.
• Sample Day 210 (long term immunity is established) – Expected results:
  • T&B cells (central) should be steadily present and
  • CD 80 and CD 86 should be over 20%
  • CD 28 on B and T lineage should be above 10%
  • If memory cells are not well established on Day 210 then a 2nd round of Clavic-Q-RE is recommended (not included in the package).

• Whether the patient will need a booster or a repeat of the Clavic-Q-RE will ultimately be decided by the scientists at the lab.
• Patients are eligible for one single booster per paid round of the therapy.
• A booster request must be submitted within 60 days of the Day 120 Immune Frame results posting.
• A booster is no longer being offered after Day 120 results.
• Once a booster is given, the follow up of Day 210 is not offered, indeed, a follow up after 90 days of the booster will be performed and included in the package price.

• Clavic-Q-RE has not been evaluated in children and is not recommended. They have an immature immune system and we do not know the effect of the immune system and development of self- tolerance. Additionally, children have an active thymus gland, and their immune system is under development.