1
00:00:02.562 --> 00:00:06.462
Will Hamilton: This is a video explainer for the microcart study.

2
00:00:08.352 --> 00:00:20.132
Will Hamilton: MicroCART is a unique study investigating the microscopic bugs, or microbes, that live and can cause infections in people with blood cancer treated with CAR-T therapy.

3
00:00:20.242 --> 00:00:30.362
Will Hamilton: My name is Dr. William Hamilton, and Chief Investigator for the study, and in this video, I'll explain why we're carrying out the research, and how the research is being done.

4
00:00:31.622 --> 00:00:43.991
Will Hamilton: For background, people with blood cancer are at higher risk of getting infections because of problems with their immune system. Infections are caused by tiny bugs or microbes, like the flu virus.

5
00:00:44.632 --> 00:00:51.542
Will Hamilton: Microbes also naturally live in the body, and that's called our microbiome, which is an important part of our health.

6
00:00:52.622 --> 00:01:05.772
Will Hamilton: CAR T therapy is an advanced treatment for certain blood cancers. It uses your body's own immune cells to fight cancer cells. After CAR-T therapy, some people can remain vulnerable to infections.

7
00:01:07.192 --> 00:01:19.202
Will Hamilton: We will study the microbes that live and cause infections in patients with B-cell lymphoma that are receiving CAR-T treatment to work out ways to prevent and treat infections in patients.

8
00:01:20.192 --> 00:01:22.591
Will Hamilton: There are four objectives to the study.

9
00:01:22.722 --> 00:01:32.472
Will Hamilton: For patients with B-cell lymphoma given CAR-T therapy, we will determine the rate and impact that infections have up to 1 year after CAR-T therapy.

10
00:01:33.112 --> 00:01:43.211
Will Hamilton: We will identify risk factors for developing infections after CAR-T therapy in these patients, to understand which patients are at highest risk of getting infections.

11
00:01:43.682 --> 00:01:53.731
Will Hamilton: We'll describe the microbes causing infections in detail, including any resistance to our treatments and vaccines, such as antibiotic resistance.

12
00:01:54.282 --> 00:02:06.531
Will Hamilton: And we will investigate how the microbiome changes over the course of CAR T treatment, and how this affects patient outcomes. We'll particularly focus on the microbiome in the gut and of the nose.

13
00:02:08.412 --> 00:02:16.961
Will Hamilton: The study is observational, meaning there is no change at all to the patient's treatment in the UK National Health Service.

14
00:02:17.512 --> 00:02:26.681
Will Hamilton: We will follow up what happens to a group of patients with lymphoma receiving CAR T treatment for one year after they have their CAR T cells.

15
00:02:27.562 --> 00:02:33.912
Will Hamilton: That will include looking at any infections they get, and any treatments they receive, such as antibiotics.

16
00:02:34.182 --> 00:02:52.501
Will Hamilton: In addition, we'll collect 3 types of sample, a nose swab, a stool or poo sample, and a blood sample, at 3 scheduled time points to study the bugs in the samples and the patient's immune system. And on the next slide, I'll go into more detail on when those time points are.

17
00:02:53.212 --> 00:02:58.882
Will Hamilton: The study is open to adults with B-cell lymphoma that are receiving CAR-T therapy.

18
00:02:59.182 --> 00:03:03.082
Will Hamilton: We're aiming to recruit 120 patients into this study.

19
00:03:03.262 --> 00:03:08.592
Will Hamilton: Each participant will receive a £25 Amazon voucher for taking part.

20
00:03:10.722 --> 00:03:15.202
Will Hamilton: This slide goes into more detail on the study protocol for participants.

21
00:03:16.582 --> 00:03:29.082
Will Hamilton: For people who agree to take part in the study, they will give informed consent, and we'll collect data about those patients, from their medical records, and by asking the patients some questions when they sign up to the study.

22
00:03:29.392 --> 00:03:36.292
Will Hamilton: We'll follow up what happens to them, such as any infections that they develop, and any treatments they receive by looking at their medical records.

23
00:03:36.322 --> 00:03:51.791
Will Hamilton: We'll also collect samples at 3 time points. The samples are a nose swab, a stool or poo sample, and a blood sample. The nose swab is just of the front part of the nose by gently inserting a swab into the front of the nostril.

24
00:03:52.032 --> 00:03:54.781
Will Hamilton: It shouldn't be too onerous to take.

25
00:03:55.842 --> 00:04:01.311
Will Hamilton: These are routine samples collected as part of the NHS, and very low risk to the participant.

26
00:04:01.992 --> 00:04:05.722
Will Hamilton: The first sample is collected before CAR-T therapy starts.

27
00:04:06.282 --> 00:04:21.001
Will Hamilton: The second sample is collected 7-14 days after the CAR T cells are put into the patient. It's anticipated both of the first and second sample will happen while the patient is in hospital, starting their CAR T treatment.

28
00:04:21.412 --> 00:04:31.272
Will Hamilton: The third sample is a recovery sample, 3-4 months after CAR T treatment, and it's anticipated that that will be in a routine hematology outpatient clinic.

29
00:04:32.072 --> 00:04:44.702
Will Hamilton: Those are the three scheduled time points. In addition, patients will be given a pack of nose swabs to take home with them, and over the 12 months of follow-up after they receive their CAR T-cells, when patients

30
00:04:44.702 --> 00:04:53.841
Will Hamilton: have symptoms of a cold or flu-like illness, they can collect their own nose swabs and post them into the study team using provided envelopes.

31
00:04:55.582 --> 00:05:10.521
Will Hamilton: For this study, we will study the bugs that are present in the samples, the nose swabs and the poo samples, including looking at the genetic code of the bugs. And we can look at the patient's immune system primarily by analyzing the blood samples.

32
00:05:11.782 --> 00:05:25.861
Will Hamilton: The study will run for 5 years, from 2026 to 2031. Three main phases, recruiting patients for the study and following up what happens to them in the first two years, then analyzing all of the data and the samples that are collected.

33
00:05:25.862 --> 00:05:31.962
Will Hamilton: And finally, the results of the study expected in the last couple of years, 2029 to 2031.

34
00:05:33.552 --> 00:05:48.932
Will Hamilton: The study is run through Cambridge University Hospital's NHS Foundation Trust and Cambridge University, who are the joint sponsors, and we're working with collaborators in the NHS and haematology centres that are recruiting patients for the study.

35
00:05:49.342 --> 00:05:56.342
Will Hamilton: The study is funded by Blood Cancer UK, with additional funding from the NIHR and Welcome Sanger Institute.

36
00:05:58.272 --> 00:06:04.931
Will Hamilton: There's a website for the study where you can find out more at www.micro-cart.org.

37
00:06:05.252 --> 00:06:17.752
Will Hamilton: And a study email that you can email if you have any questions, that's micro-cart at medschool, M-E-D-S-C-H-L dot cam.ac.uk.

38
00:06:18.072 --> 00:06:19.367
Will Hamilton: Thank you for listening.