Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy B – Relapsed/Refractory Richter Transformation (RT)

This study is investigating a new cell therapy, called Tecartus, for adults who have a specific type of blood cancer known as Richter Transformation. This is for people whose cancer has either returned after treatment (relapsed) or has not responded to previous treatments (refractory). The main goal is to find out how effective Tecartus is at shrinking or getting rid of the cancer and to check for any side effects. Researchers will be carefully monitoring participants to see how many achieve a significant improvement in their condition. It's a Phase 2 study, meaning it's still in the earlier stages of testing, but it could offer a new option for patients with this rare and serious condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Kite Pharma Inc.

Enrolment target

Start

13 Feb 2023

Relapsed/refractory Richter Transformation (RT)

What is this study about?

This clinical trial, called ZUMA-25, is looking into a new treatment for a type of blood cancer known as Richter Transformation (RT). RT is a rare and aggressive form of cancer that can develop in people who have chronic lymphocytic leukaemia (CLL). For this study, we're focusing on adults whose Richter Transformation has either come back after treatment (relapsed) or hasn't responded to earlier treatments (refractory). This means that standard treatments haven't worked or are no longer working for them.

The main treatment being studied here is called Tecartus (which is also known by its medical name, brexucabtagene autoleucel). This is a cutting-edge type of therapy where a patient's own immune cells, called T-cells, are collected, specially trained in a lab to find and fight cancer cells, and then given back to the patient. This approach is hoped to be more effective for this specific cancer.

The study aims to carefully check how well Tecartus works for people with RT. Researchers will be looking at how many patients have their cancer shrink or disappear completely after treatment. They will also be monitoring patients closely for any side effects. This research is important because it could lead to a new and effective treatment option for patients facing a very challenging type of cancer.

Key takeaways

The study is for adults with Richter Transformation that has returned or not responded to previous treatments.
It investigates a new cell therapy called Tecartus.
The goal is to see how effective Tecartus is at treating the cancer and to monitor its safety.
Participants will receive regular medical check-ups, blood tests, and scans.
This is a Phase 2 study, an early stage of testing for new treatments.

Who may be eligible?

To be part of this study, you must be an adult, aged 18 or older. Both men and women can participate. The study is specifically for individuals diagnosed with Richter Transformation.

Crucially, your Richter Transformation must have either come back after you've already had treatment for it (this is called 'relapsed') or it must not have improved with previous treatments ('refractory'). This means that standard treatments haven't been successful for your specific condition.

There will be other detailed medical checks to make sure the study is a safe option for you and that you meet all the necessary health requirements. Your doctor will be able to discuss these with you.

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 Richter Transformation?
Has your Richter Transformation come back after treatment or not responded to previous treatments?
Are you able to attend regular hospital visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new cell therapy called Tecartus. Before receiving Tecartus, you may have other medications, such as chemotherapy drugs (like IMBRUVICA, VINCRISTINE, FLUDARABINE, PREDNISOLONE, IFOSFAMIDE, METHYLPREDNISOLONE, ETOPOSIDE, DOXORUBICIN, MESNA, CYCLOPHOSPHAMIDE, DEXAMETHASONE, OXALIPLATIN, GEMCITABINE, CARBOPLATIN, RITUXIMAB), which doctors sometimes use to prepare your body for the cell therapy. The Tecartus treatment itself involves an infusion, where the specially prepared cells are given to you through a drip.

Throughout the study, you'll need to attend regular hospital visits for assessments. These will include blood tests, physical examinations, and scans to see how you're responding to the treatment and to check for any side effects. The study will continue for a period to track your progress and long-term health. The total duration of your participation will depend on how you respond to the treatment and the follow-up schedules, which the medical team will explain in detail.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new, cutting-edge treatment (Tecartus) for your Richter Transformation, which might be more effective than other options, especially if previous treatments haven't worked. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy medicines and the Tecartus therapy itself. These will be fully explained by the study team. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

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

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Unverified
France
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Unverified
Germany
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Unverified
Spain
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Unverified
Sweden
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Unverified
Italy
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Unverified
Netherlands
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Unverified
Austria

Common questions

What is Richter Transformation?

Richter Transformation is a rare and serious type of blood cancer that can develop in people who have chronic lymphocytic leukaemia (CLL).

What is Tecartus?

Tecartus is a special cell therapy where your own immune cells are modified in a lab to fight your cancer and then given back to you.

Why is this study important?

This study could lead to a new treatment option for people with Richter Transformation whose cancer has come back or not responded to other treatments.

What is a 'Phase 2' study?

A Phase 2 study is an earlier stage of research that looks at how well a new treatment works and checks for safety in a larger group of people than a Phase 1 study.

Will I receive other medicines during the study?

Yes, you might receive other commonly used cancer medicines, often to prepare your body for the main cell therapy treatment.