Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined with Atezolizumab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

This research study is investigating a new medication called mosunetuzumab, both on its own and in combination with another drug called atezolizumab. It's designed for adult patients who have certain types of B-cell lymphoma or chronic lymphocytic leukaemia, especially if their disease has come back or hasn’t improved with previous treatments. The study has two main parts: an early (Phase I) part to find the safest dose, and then a later (Phase II) part to see how effective it is. Researchers are looking closely at any side effects, how well the treatment shrinks the cancer, and how the body processes the medication. The aim is to find better treatment options for these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Genentech Inc.

Enrolment target

Start

10 Jun 2024

B-Cell Malignancies

What is this study about?

This research study is focused on a new treatment called mosunetuzumab, sometimes given alone and sometimes alongside another drug called atezolizumab (which you might know as Tecentriq). It's designed for adult patients diagnosed with specific types of B-cell cancers, such as certain lymphomas or chronic lymphocytic leukaemia. These are conditions where the body's immune cells (B-cells) don't work properly and grow out of control.

The main reason for this study is to explore new ways to treat these cancers, especially for people whose previous treatments haven't worked or whose cancer has returned. The study is divided into two phases. In the first phase (Phase I), the doctors are mainly trying to find the safest dose of mosunetuzumab and understand any side effects. Once they've found a safe dose, the second phase (Phase II) will focus more on how well the treatment works to shrink or control the cancer.

Throughout the study, researchers will be carefully monitoring how the treatment affects patients. This includes tracking any side effects, looking at how the drug moves through the body, and most importantly, seeing if the treatment helps to reduce or eliminate the cancer. By doing this, they hope to gather important information that could lead to new and improved treatments for people living with these conditions.

Key takeaways

This study explores a new drug (mosunetuzumab) for specific B-cell cancers.
It's for adults whose cancer hasn't responded well to other treatments.
The drug is tested alone and with another medication (atezolizumab).
Researchers are looking for safety, effectiveness, and how the body handles the drug.
Participation means regular visits and monitoring, with clear explanations of risks and benefits.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

More specifically, you need to have a type of B-cell cancer that is either a Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukaemia. It’s important that your cancer has either come back after previous treatments or hasn't responded to other medicines you've tried.

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 B-cell Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukaemia?
Has your cancer come back or not responded to previous treatments?
Are you able and willing to attend regular clinic visits?

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, mosunetuzumab, which might be given either into a vein (IV) or under the skin (SC). In some parts of the study, you might also receive atezolizumab (Tecentriq). You would have regular visits to the clinic for treatments, blood tests, and check-ups to monitor your health and how the treatment is working. Doctors will look for any side effects and see how the medication levels change in your body over time. The exact number of visits and the full duration of your participation would be discussed in detail by the study team, as it varies depending on your treatment response and the study phase.

Potential risks and benefits

Taking part in this study could offer a potential benefit: access to a new treatment that is not yet widely available for your condition. This treatment might help if other options haven't worked for you. However, as with any new medication, there are potential risks, including side effects that could be mild or more serious. The study team will explain all known risks to you. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Germany

Common questions

What is mosunetuzumab?

Mosunetuzumab is a new drug being tested to treat certain types of B-cell cancers, like lymphoma and leukaemia.

What are B-cell malignancies?

These are types of cancer that start in specific immune cells called B-cells, including some lymphomas and leukaemias.

What does 'relapsed or refractory' mean?

It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

What is the purpose of combining drugs?

Sometimes, giving two drugs together can be more effective than giving just one. This study is testing mosunetuzumab both alone and with another drug, atezolizumab, to see if the combination works better.

Will I get 'Tecentriq' or 'RoActemra'?

The study mentions Tecentriq (atezolizumab) as a possible combination drug. While RoActemra is listed, it's typically used for managing certain side effects and not as a primary cancer treatment in this type of study. The study team will clarify exactly what treatments you would receive.