The plan

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This is pretty technical but this is the basic plan.  If you have any questions then post them and I will do my best to answer  

Lymphodepletion: Day 9- to Day- 3 (They kill my T Cells)

Before you receive the CB-010 infusion, you will be given lymphodepletion consisting of fludarabine and cyclophosphamide. Cyclophosphamide will be given on 2 separate days (Day -9 and Day -8) followed by fludarabine given on 5 separate days (Days - 7, -6, -5, -4, and -3). Your doctor will discuss with you whether you need to be in the hospital during any part of the lymphodepletion. (Could have some nasty side effects here.  So far plan is outpatient.)  

During lymphodepletion days, you will have the following assessments:

• Physical exam

• Review of your current medicines

• Recording of any side effects

• Blood tests: chemistry and blood count

• Approximately 4.5 tablespoons or 66 mL of blood will be drawn in total to complete the blood tests

CB-010 Administration (Day 0) and CB-010 Follow-up (Day 1through Day 7) (They give me T cells to kill my bad B cells.)

You will be admitted to the hospital the day prior to, or the day of, CB-010 administration. You will be required to remain in the hospital for 7days after you are given the CB-010 infusion so that you can complete study required assessments and tests. On Day 0, CB-010 will be given through an IV tube placed in your hand, arm or possibly a central line if you have one.

If you do not meet the requirements for CB-010 administration, the infusion will be delayed until the study doctor determines that you meet the requirements to receive the infusion. If giving CB-010 is delayed by more than 7 days, your doctor will discuss with you your options.

During the CB-010 administration (Day 0) through CB-010 follow up (Day 1 through Day 7) after you receive CB-010 infusion, the following assessments will be done:

• Physical exam.

• Review of your current medicines

Review of any side effects

• Blood tests - chemistry, blood count, coagulation tests, analysis of DNA from the tumor, detection of CB-010 in the blood, detection of antibodies (antibodies are part of the immune system) to CB-010, and evaluation of your immune cells, inflammatory cells, and proteins that may appear with inflammation

• Approximately 8.1 tablespoons or 120 mL of blood will be drawn in total to complete the blood tests

• Possible lumbar puncture - A lumbar puncture may be performed after receiving CB-010.

Your doctor will assess your physical condition, and if you require a lumbar puncture, your study doctor will discuss this procedure with you. (Let’s hope not!)

You will be able to leave the hospital when your study doctor believes it is in your best interest to do so.

Various followups after this. 

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