Screening period (up to 2 weeks)

Assessments are carried out to make sure that you and the trial are a good fit.

Pre-treatment period (3 weeks)

Collecting your T cells
During a process called “leukapheresis,” your blood passes through a machine that collects some of your T cells × T cell A type of white blood cell that helps your body fight infections and diseases. In investigational CAR-T therapy, your own T cells are collected and changed in a lab so they can better recognize and attack harmful cells. . The rest of your blood is then returned to your body
Making the CAR-T cells
Your T cells are sent to a lab where they are genetically modified so they can target the harmful B cells × B cell A type of white blood cell that helps protect your body by making antibodies. In some diseases, B cells can become overactive or damaged, which is why treatments like CAR-T therapy may target them. . The modified cells are called CAR-T cells
Preparing for your investigational CAR-T therapy
Next, your body needs to get ready for the investigational CAR-T × CAR-T cell Your own immune cells (T cells) that have been modified in a lab to recognize and target harmful B cells. cells. In a process called “ lymphodepletion × Lymphodepletion A short course of medicine given before your investigational CAR-T therapy infusion to make space in your immune system and help the new investigational CAR-T cells work better. ,” you’ll be given an infusion × Infusion When medicine or CAR-T cells are given slowly into a vein through an intravenous (IV) or central line. of medicine designed to reduce the number of white blood cells in your body so there is space for the new investigational CAR-T cells

Treatment period (2 weeks)

Receiving your investigational CAR-T therapy
You’ll be given your investigational treatment in a one-time infusion into the vein
Monitoring after your investigational CAR-T therapy
After the infusion × Infusion When medicine or CAR-T cells are given slowly into a vein through an intravenous (IV) or central line. , you’ll need to stay in hospital for at least 2 weeks so the trial team can closely monitor × Monitoring Regular checks, examinations, and visits done by the trial team to follow your health and safety during and after treatment. you. After that, you will need to stay within 2 hours’ travel of the hospital for a further 2 weeks

Follow-up period (up to 5 years)

For 8 weeks after treatment, you will need to come into the hospital at least once a week.

After this initial period, visits become less frequent

Long-term follow-up trial (up to 10years)

Once you have completed the trial, you may be asked to join a long-term follow-up trial for up to an additional 10 years to understand more about the ongoing effects of the investigational CAR-T cell therapy
Participation in the follow-up trial is voluntary. You don’t have to be involved in the long-term follow-up trial, even if you participated in the main trial

Screening period (up to 2 weeks)

Assessments are carried out to make sure that you and the trial are a good fit.

Pre-treatment period (4 weeks)

Collecting your T cells

During a process called “leukapheresis,” your blood passes through a machine that collects some of your T cells × T cell A type of white blood cell that helps your body fight infections and diseases. In investigational CAR-T therapy, your own T cells are collected and changed in a lab so they can better recognize and attack harmful cells. . The rest of your blood is then returned to your body

Making the CAR-T cells

Your T cells are sent to a lab where they are genetically modified so they can target the harmful B cells × B cell A type of white blood cell that helps protect your body by making antibodies. In some diseases, B cells can become overactive or damaged, which is why treatments like CAR-T therapy may target them. . The modified cells are called CAR-T cells

Preparing for your investigational CAR-T therapy

Next, your body needs to get ready for the investigational CAR-T × CAR-T cell Your own immune cells (T cells) that have been modified in a lab to recognize and target harmful B cells. cells. In a process called “ lymphodepletion × Lymphodepletion A short course of medicine given before your investigational CAR-T therapy infusion to make space in your immune system and help the new investigational CAR-T cells work better. ,” you’ll be given an infusion × Infusion When medicine or CAR-T cells are given slowly into a vein through an intravenous (IV) or central line. of medicine designed to reduce the number of white blood cells in your body so there is space for the new investigational CAR-T cells

You’ll be given medicines to control your systemic sclerosis

Treatment period (2 weeks)

Receiving your investigational CAR-T therapy

You’ll be given your investigational treatment in a one-time infusion into the vein

Monitoring after your investigational CAR-T therapy

After that, you’ll need to stay in hospital for at least 2 weeks so the trial team can closely monitor × Monitoring Regular checks, examinations, and visits done by the trial team to follow your health and safety during and after treatment. you. After that you will need to stay within 2 hours’ travel of the hospital for a further 2 weeks

Follow-up (up to 5 years)

For up to 8 weeks after CAR-T treatment, you will need to come into the hospital at least once a week. Visits can take up to 4 hours

After this initial period, visits become less frequent

Long-term follow-up trial (up to 15 years from investigational CAR-T cell therapy)

Once you have completed the trial, you may be asked to join a long-term follow-up trial for up to a combined total of 15 years from receiving investigational CAR-T therapy, to understand more about the ongoing effects of the investigational CAR-T cell therapy

Participation in the follow-up trial is voluntary. You don’t have to be involved in the long-term follow-up trial, even if you participated in the main trial

Data We Collect & Why:

  • Reply to your requests, inquiries and comments;
  • Respond to circumstances permitted or required by law, including defending and bringing legal actions; and
  • If applicable, only on clinical trial recruitments web sites, to determine whether you may be eligible to participate in Sponsor’s Study. During the recruitment period for the Study, we may provide your screening information and contact information to one of our Sponsor’s investigator sites nearest to you.

To control data you have already submitted, make a data request here.

Data you submit is handled according to our Privacy Policy and web site user agreements.

We Do Not Sell Your Data to 3rd Parties

We do not sell data to third parties. Data you submit is handled according to our Privacy Policy and web site use agreements.

To control data you have already submitted, or to log a do not sell data request, make a data request here.