Skip to content
Clinical Trials – home

Brexucabtagene Autoleucel: A Promising Treatment for Mantle Cell Lymphoma

4 / 11
trials open to patients / all trials
10+
Countries

In short

A new clinical trial is investigating the use of Brexucabtagene Autoleucel, a promising CAR T-cell therapy, in combination with Pirtobrutinib for patients with relapsed or refractory mantle cell lymphoma. This study aims to evaluate the effectiveness and safety of this innovative treatment approach, potentially offering new hope for patients with this challenging form of blood cancer.

At a glance

Study Type
Phase 2, open-label, randomized, multicenter clinical trial
Condition
Relapsed/refractory mantle cell lymphoma (R/R MCL)
Main Treatments
Brexucabtagene Autoleucel (CAR T-cell therapy) and Pirtobrutinib
Study Arms
Arm A: Concurrent Pirtobrutinib with Brexucabtagene Autoleucel; Arm B: Pirtobrutinib as bridging therapy only
Primary Outcomes
Progression-free survival compared to historical control and between arms
Secondary Outcomes
Severe ICANS and CRS rates, Overall Response Rate, Overall survival
Number of Participants
60 (30 in each arm)

What is Brexucabtagene Autoleucel?

Brexucabtagene Autoleucel, also known by its brand name Tecartus, is an innovative type of cancer treatment. It belongs to a class of therapies called CAR T-cell therapy, which stands for Chimeric Antigen Receptor T-cell therapy. This treatment is specifically designed to target and fight certain types of cancer cells in your body.

Target Condition: Mantle Cell Lymphoma

Brexucabtagene Autoleucel is primarily used to treat a condition called Mantle Cell Lymphoma (MCL). MCL is a rare type of cancer that affects white blood cells called B lymphocytes, which are an important part of your immune system. This treatment is particularly valuable for patients with relapsed or refractory MCL, which means the cancer has either returned after initial treatment or did not respond well to other treatments.

How Brexucabtagene Autoleucel Works

Brexucabtagene Autoleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy. Let's break down what this means:

  • Autologous: This means the therapy uses your own cells. Doctors collect some of your T-cells (a type of immune cell) from your blood.
  • CD19-directed: The collected T-cells are modified in a laboratory to target a specific protein called CD19, which is found on the surface of cancerous B-cells in MCL.
  • Chimeric Antigen Receptor (CAR): This is a special protein added to your T-cells that helps them recognize and attack cancer cells more effectively.

Once modified, these CAR T-cells are multiplied in the lab and then infused back into your body. They act like "super-soldiers" in your immune system, specifically targeting and destroying cancer cells that have the CD19 protein.

Current Clinical Trial

A new clinical trial is currently underway to further study the effectiveness of Brexucabtagene Autoleucel. This trial is exploring how combining Brexucabtagene Autoleucel with another drug called Pirtobrutinib might improve outcomes for patients with relapsed or refractory Mantle Cell Lymphoma. Here are some key points about the trial:

  • It's a Phase 2, open-label, randomized study.
  • The trial involves two groups (arms) of patients:
    • Arm A: Patients receive Pirtobrutinib before and during Brexucabtagene Autoleucel treatment.
    • Arm B: Patients receive Pirtobrutinib only before Brexucabtagene Autoleucel treatment.
  • The main goal is to see if adding Pirtobrutinib improves how long patients live without their cancer getting worse (progression-free survival).

Potential Benefits

The clinical trial aims to assess several potential benefits of Brexucabtagene Autoleucel treatment:

  1. Improved Progression-Free Survival (PFS): This means patients may live longer without their cancer getting worse.
  2. Better Overall Response Rate (ORR): More patients may see their cancer shrink or disappear after treatment.
  3. Increased Overall Survival (OS): Patients may live longer overall compared to those receiving standard treatments.

Possible Side Effects

While Brexucabtagene Autoleucel can be very effective, it's important to be aware of potential side effects. The clinical trial is monitoring two main side effects:

  1. Immune Cell-Associated Neurotoxicity Syndrome (ICANS): This is a condition that can affect the nervous system. The trial is specifically looking at severe cases (grade 3 or higher) that occur within 60 days after the CAR T-cell infusion.
  2. Cytokine Release Syndrome (CRS): This is a condition where the immune system becomes overly active, causing symptoms like fever, nausea, and difficulty breathing. Again, the trial is focusing on severe cases (grade 3 or higher) within 60 days of treatment.

It's crucial to discuss these potential side effects with your healthcare provider to understand the risks and benefits of this treatment.

Questions people often ask

Conditions where Brexucabtagene Autoleucel is being studied

Each condition opens its own overview and trial list

Trials with Brexucabtagene Autoleucel

Recruiting trials first

See all 11 →
Quick filters
  • Participants:All ages
  • Participants:Adults
  • Participants:Adults
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.