Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

This research trial is for adults suffering from B-cell acute lymphoblastic leukaemia (ALL), a cancer of the white blood cells, where the disease has either returned after treatment or hasn't responded well to previous therapies. The study is investigating a new treatment called AUTO1, which is a type of CAR T-cell therapy. This therapy uses a patient's own immune cells, specially modified to fight the cancer. The main goals of the study are to understand how safe AUTO1 is and how well it works to reduce or clear the cancer in participants. It's hoped this treatment could offer a new option for patients when standard treatments haven't been successful.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Autolus Limited

Enrolment target

153

Start

03 Jun 2020

Estimated completion

30 Jun 2029

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

What is this study about?

This study is investigating a new and advanced treatment called CAR T-cell therapy, specifically AUTO1, for adults who have a form of blood cancer called B-cell acute lymphoblastic leukaemia (ALL). This is an important study because it focuses on patients whose cancer has either come back after treatment (relapsed) or hasn't responded well to standard therapies (refractory). For these patients, finding new and effective treatments is crucial.

CAR T-cell therapy is a type of immunotherapy. It involves taking some of a patient's own immune cells, called T-cells, and genetically modifying them in a lab. These modified T-cells are then given back to the patient. They are designed to recognise and attack cancer cells more effectively. In this study, the AUTO1 cells are specifically trained to target a protein called CD19, which is often found on B-ALL cancer cells.

The study is being carried out in two main parts (Phase 1b and Phase 2) to gather more information. Researchers will be carefully checking how safe AUTO1 is for patients and how effective it is at reducing or clearing the cancer. The hope is that this treatment could offer a valuable new option for adults fighting relapsed or refractory B-cell ALL.

Key takeaways

Targets adults with relapsed or refractory B-cell ALL.
Uses a new type of immunotherapy called CAR T-cell therapy (AUTO1).
Aims to check the safety and effectiveness of AUTO1.
Involves collecting your own immune cells to create the treatment.
Requires careful screening and ongoing monitoring.
Could offer a new treatment option when others haven't worked.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years or older, and generally well enough to take part. You must have B-cell acute lymphoblastic leukaemia (ALL) that has either returned after treatment or hasn't responded to previous treatments. For some types of ALL, like Ph+ ALL, there are specific requirements about previous treatments you might have tried.

Your cancer cells must also show a specific marker called CD19. The study is looking for patients with different levels of cancer cells in their bone marrow, ranging from 5% or more, to very low levels that can only be detected with sensitive tests.

There are also reasons why you might not be able to join. For example, if your ALL is only in certain places outside the bone marrow, or if you have other serious health conditions like uncontrolled infections, or certain past brain or nerve problems. Also, if you've had a similar CD19-targeting treatment before (except for one called blinatumomab, depending on your reaction to it), you likely wouldn't be eligible.

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 ALL that has come back or not responded to treatment?
Are your ALL cells identified as CD19 positive?
Are you generally well enough to take part in a clinical study?
Do you have good kidney, liver, lung, and heart function?
Have you not had certain serious infections or nerve conditions?

Answer every question to see your result.

What does participation involve?

If you are interested and meet the initial criteria, your journey in the study would begin with a 'screening' stage. This involves tests to confirm you're suitable. Once confirmed, you would have a procedure called 'leukapheresis' where some of your blood is taken, and specific white blood cells (T-cells) are collected to make the AUTO1 treatment.

Next, you would receive 'pre-conditioning' treatment, which helps prepare your body for the AUTO1 cells. Then, the AUTO1 cells will be given to you in two separate doses: one on Day 1 and another around Day 10. After the treatment, you'll enter the 'follow-up' stage, which involves regular check-ups and tests to monitor your health and how well the treatment is working. The exact length of follow-up will be explained by the study team, but it's important to be prepared for ongoing monitoring for a period after the main treatment.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as gaining access to a new and innovative treatment (AUTO1) for your ALL that might not be available otherwise, especially if previous treatments haven't worked. However, it's also important to understand there are potential risks. As with any new treatment, there could be side effects, some of which may be serious. The study team will explain these in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

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

City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California San Diego Health (UCSD)
Verified postcode
La Jolla, United States
University of California Davis (UC Davis)
Verified postcode
Sacramento, United States
University of California San Francisco (UCSF)
Verified postcode
San Francisco, United States
Colorado Blood Cancer Institute (CBCI)
Verified postcode
Denver, United States
University of Miami
Verified postcode
Miami, United States
H Lee Moffitt Cancer Center
Verified postcode
Tampa, United States
Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States
University of Chicago
Verified postcode
Chicago, United States
University of Kansas
Verified postcode
Kansas City, United States
University of Maryland Medical Center
Verified postcode
Baltimore, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States

Common questions

What is CAR T-cell therapy?

It's a treatment where your own immune cells are specially trained in a lab to find and destroy cancer cells.

What does 'relapsed or refractory' mean?

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

Will I have to stay in the hospital?

The study involves hospital visits for certain procedures, including receiving the treatment, and close monitoring afterward. The team will explain the exact schedule.

Is this a cure for ALL?

This is a research study to see how safe and effective AUTO1 is. While we hope for the best outcomes, it's not guaranteed to be a cure.

Can I continue my regular medication?

You'll need to discuss all your current medications with the study team, as some might need to be stopped or adjusted during the trial.