AuthorisedTherapeutic exploratory (Phase II)Interventional

Teclistamab plus autologous lymphocytes infusion for the treatment of relapsed/refractory Multiple Myeloma (TALIM). MM0125

This study, called TALIM, is for people with multiple myeloma that has returned or not responded well to previous treatments. It explores using a medicine called teclistamab alongside a special treatment where a patient's own immune cells are given back to them. The main goal is to find out how long people remain in remission (without their disease getting worse) at 18 months after starting this combination. The study also looks at how well people respond to the treatment, how long they live, and whether the treatment is safe. This is a Phase II study, meaning we're exploring how effective and safe this new combination might be.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Gimema Franco Mandelli Onlus

Enrolment target

Start

14 Apr 2026

refractory/relapsed multiple myeloma

What is this study about?

This study is called TALIM and it's looking at a new way to treat multiple myeloma, which is a type of cancer that affects plasma cells in the bone marrow. Sometimes, multiple myeloma can be difficult to treat because it comes back after treatment or doesn't respond well to the usual medicines. This is what we call 'relapsed' or 'refractory' multiple myeloma.

The study is using a medicine called teclistamab. This medicine works by helping your own immune system fight the cancer cells. Researchers want to see if combining teclistamab with another treatment, where a patient's own immune cells are collected and then given back, can be more effective. This second part is sometimes called an 'autologous lymphocytes infusion', which just means putting your own immune cells back into your body.

The main thing researchers want to find out is how long people stay well after this combined treatment. They are specifically looking at how long people remain in remission, meaning the cancer is under control, 18 months after starting the combination therapy. They will also be checking how well the treatment works generally, how long people live, and carefully monitoring for any side effects to make sure the treatment is as safe as possible.

Key takeaways

This study explores a new combination treatment for multiple myeloma.
It's for people whose multiple myeloma has returned or not responded to other treatments.
The treatment involves a medicine called teclistamab with a patient's own immune cells.
Researchers want to see how long people stay well after this combined therapy.
Safety is a key focus, with close monitoring for side effects.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women can take part in this research.

The study is specifically for people who have been diagnosed with multiple myeloma that has either come back after previous treatments (relapsed) or has not responded well to other treatments (refractory). This means you would have already received some treatment for your multiple myeloma.

There will be other detailed health checks to make sure the treatment is safe for you and that you meet all the specific requirements for the study. Your doctor will be able to tell you if this study might be a good fit for your individual situation.

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?
Have you been diagnosed with multiple myeloma?
Has your multiple myeloma come back or not responded well to past treatments?
Are you able to attend regular clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, teclistamab, likely in combination with your own immune cells. You would have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. The study will track how long you respond to the treatment for at least 18 months from the combination therapy, and your overall health for 24 months from when you start teclistamab. The exact number of visits and tests would be clearly explained by the study team. You would also be monitored carefully for any side effects throughout the study. The total duration of your participation would involve the treatment period and follow-up assessments.

Potential risks and benefits

Participating in this study might offer you access to a new treatment combination for your multiple myeloma that might not be available otherwise, potentially helping to control your disease. However, like all medical treatments, there are potential risks and side effects. These will be carefully monitored, with a particular focus on immune-related reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in your bone marrow.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment or hasn't responded well to previous treatments.

What is teclistamab?

Teclistamab is a medicine that helps your own immune system target and fight cancer cells.

What is an 'autologous lymphocytes infusion'?

It's a treatment where some of your own immune cells are collected and then given back to you.

What is a Phase II study?

A Phase II study explores how effective and safe a new treatment or combination of treatments might be.