About
Micro-CART is a unique study investigating the microscopic bugs ('microbes') that live and can cause infections in people treated with CAR-T therapy.
CAR-T therapy is a new type of treatment in which a person's immune cells are reprogrammed to fight cancer cells. CAR-T therapy can be very successful in treating a type of blood cancer called B-cell lymphoma. However, these patients can remain vulnerable to infections long-term after receiving CAR-T treatment, including bacteria and viruses such as flu and Covid-19.
The overall aim of this study is to improve our understanding of infections that may occur in patients with B-cell lymphoma receiving CAR-T therapy. We will study the microbes that naturally live in the body, called the microbiome, and any microbes that cause infections in these patients such as the flu virus. By investigating both the immune system and microbes in CAR-T patients, ultimately we hope to better prevent and treat infections in these patients.
Background
-
People with blood cancer are at higher risk of infections because of problems with their immune system.
-
Infections are caused by microbes (tiny bugs), like bacteria and viruses.
-
Microbes also naturally live in the human body, called our ‘microbiome’. A healthy microbiome is important for our health.
-
CAR-T therapy is an advanced treatment for certain blood cancers. It uses your body’s own immune cells to fight the cancer cells.
-
After CAR-T therapy people can remain vulnerable to infections long-term.
-
We want to understand what microbes live and cause infections in patients after CAR-T therapy, and which patients are at highest risk of getting infections. We will study the microbiome, the microbes causing infections, the immune system, and risk factors for getting infections after CAR-T therapy.
We are especially interested in the microbes living in the gut, which can be detected in poo samples, and the nose, which can be detected using non-invasive swabs of the front part of a person's nostrils. Using these samples, we will be able to analyse the range of bugs living in the gut and nose, any viruses present, and antibiotic resistance, which make bacterial infections harder to treat. We can also use blood samples to study how a person's immune system affects their risk of getting infections.
Aims
The study has four main aims:
-
To determine the rate and impact of infections occurring up to one year after CAR-T therapy for treatment of adult patients with high grade B-cell lymphoma.
-
To identify risk factors for developing infections after CAR-T therapy in these patients (to understand which patients are at highest risk).
-
To describe the microbes causing infections in CAR-T patients in detail.
-
To investigate how the microbiome changes over the course of CAR-T treatment and how it affects patient outcomes.
Study design
The study is a prospective longitudinal cohort study, meaning we will follow up a group of patients treated with CD19 CAR-T therapy and see what infections they get. CD19 is a marker found on B-cells, and CD19 CAR-T therapy is used to treat B-cell cancers. We will collect data and samples from participants with high grade B-cell lymphoma to study their microbiome, the genetic makeup of pathogens that cause infections, and risk factors for infection.
The study is open to adult patients (age older than 18 years) with high grade B-cell lymphoma, treated with CD19 CAR-T therapy (any CAR-T product), who have capacity to consent to participate and are able to donate samples of their stool (poo), nose swabs (similar to Covid-19 tests), and blood samples at three scheduled time points. Information on study sites currently recruiting patients can be found here and there is a video explainer here.
We will use several methods to analyse the microbes present in the samples. One method is called metagenomic sequencing, where all the bugs present have their genetic code sequenced simultaneously in a single test. We will also use whole genome sequencing to study individual bugs in detail. The participant's immune system will also be studied by analysing the blood samples, for example by checking antibodies against viruses like flu and Covid-19 viruses.
The study will build a comprehensive picture of infections arising in patients with B-cell lymphoma after CD19 CAR-T therapy, and the microbes that live in these patients. We will study how we can best prevent and treat infections after CD19 CAR-T therapy.
The study received a favourable outcome after review by the Bloomsbury Research Ethics Committee in May 2026. Recruitment will start in summer 2026. Information on study sponsorship and funding can be found here.
Study diagram
Timeframe
The study will run for five years, from 1st June 2026 to 31st May 2031. It is anticipated that patients will be recruited between June 2026 to May 2028. Patients will be followed up for 12 months after they receive their CAR T-cells. The data will be analysed from 2027- 2030. Results are expected 2029-2031.
Results will be presented at conferences and written up in scientific/ medical journals. Accompanying blog articles will be published on this website.