RecruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide

This study, called SMART101, is for adult patients with blood cancers such as leukaemia or myelodysplastic syndrome. These patients are undergoing a special type of stem cell transplant from a partially matched family donor, followed by a particular chemotherapy drug called cyclophosphamide. The main goal is to test a new injection called SMART101 (which contains special immune cells) to see how safe it is and if it helps the patient's immune system get stronger more quickly after the transplant. A stronger immune system could help reduce complications and improve recovery. The study is in early stages, combining Phase 1 and Phase 2, meaning it's still gathering important safety information while also looking for positive effects.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Smart Immune SAS

Enrolment target

Start

06 Jun 2023

Estimated completion

01 Jul 2026

Hematological Malignancies

What is this study about?

This clinical trial is designed for adult patients who have certain blood cancers, like leukaemia or myelodysplastic syndrome. These conditions affect your blood-forming cells and often require a treatment called a stem cell transplant. In this particular study, patients will be receiving a stem cell transplant from a donor who is a partial match, usually a family member (this is called a haploidentical transplant).

After this type of transplant, patients are typically given a drug called cyclophosphamide to help prevent severe complications. The study is investigating a new treatment called SMART101, which is an injection containing special immune-boosting cells. The main idea behind SMART101 is to help your body's immune system recover and rebuild itself more quickly after the transplant and the cyclophosphamide treatment. A faster recovery of your immune system can be very important in fighting off infections and other problems that can occur when your immune system is weak.

The researchers want to find out two main things: first, if SMART101 is safe to use in these patients, and second, if it's effective in speeding up the recovery of their immune system. By helping the immune system get back on its feet sooner, the hope is that patients will have a smoother recovery and better long-term health after their stem cell transplant.

Key takeaways

This study evaluates a new treatment, SMART101, for specific blood cancers.
It's for adults having a partially-matched (haploidentical) stem cell transplant.
The goal is to improve immune system recovery after transplant.
Researchers are checking its safety and how well it works.
This is an early-stage study (Phase 1/2) for a new cell therapy.
Participation involves close monitoring during and after treatment.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have certain types of blood cancer like AML, ALL, or MDS. You must be planned to have a specific type of stem cell transplant from a partially matched family donor, followed by a particular chemotherapy treatment (post-transplant cyclophosphamide).

There are also some general health checks to make sure you're well enough for the study. For example, your heart and lung function need to be at a certain level, and your liver and kidney test results should be within a healthy range. You also need to be able to carry out most daily activities without too much difficulty.

You would not be able to join if you've already had a stem cell transplant from a donor before. Also, if you've recently received other cell therapies or experimental treatments within the last four weeks, you likely wouldn't be eligible. The study needs to make sure that the effects seen are truly from SMART101 and not from other treatments you've had.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have AML, ALL, or MDS?
Are you having a partially-matched stem cell transplant with post-transplant cyclophosphamide?
Do you have good general health, including heart, lung, liver, and kidney function?
Have you not had a donor stem cell transplant before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the SMART101 injection as part of your treatment plan after your stem cell transplant and post-transplant cyclophosphamide. You would have regular check-ups, which include blood tests, physical examinations, and possibly other tests to monitor how you're doing and how your immune system is recovering. These visits will help the doctors understand the safety and effects of SMART101. The exact number and timing of visits will be explained by the study team. You'll be closely monitored for a period after the treatment, but the total duration of your active participation in the study, including follow-up, would be fully explained before you agree to join.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new and potentially effective treatment that isn't widely available yet, which might help your immune system recover faster. However, like all medical treatments, there are potential risks, including side effects from the SMART101 injection or interactions with your existing treatments. The study team will carefully monitor you for any problems. You will be given a full explanation of all known and potential risks before you decide to participate, and importantly, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
Centre hospitalier universitaire de Nantes
Verified postcode
Nantes, France· Recruiting
Hôpital Saint-Louis
Verified postcode
Paris, France· Recruiting
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a 'haploidentical' stem cell transplant?

It's a type of stem cell transplant where the donor (often a family member) is only a partial match for your immune system, rather than a full match.

What is SMART101?

SMART101 is an injection containing special immune cells designed to help your immune system recover faster after your stem cell transplant.

What does 'immune reconstitution' mean?

It means the process where your immune system rebuilds and starts working properly again after a treatment like a stem cell transplant.

Will I still receive standard treatment?

Yes, SMART101 is given in addition to your planned stem cell transplant and standard post-transplant cyclophosphamide treatment.

Is SMART101 a new drug?

Yes, SMART101 is an experimental treatment being tested in a clinical trial to understand its safety and how well it works.

How to find out more

Frédéric LEHMANN, MD

frederic.lehmann@smart-immune.com +32 (0) 492 46 23 55 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.