RecruitingRare disease

Long-term Safety Study of AUTO4 and Rituximab in Patients with Potential Malignancy Treated with Autologous CAR T Cell Therapy

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on the long-term follow-up of patients who have previously been treated with a special type of therapy called CAR T cell therapy. This therapy involves using a patient's own T cells, which are a type of immune cell, that have been genetically modified to better fight certain diseases. The diseases being studied in this trial are potential cancers that may develop in patients who have received this therapy. The main goal of the study is to monitor the long-term safety of these treatments.

The study involves two specific treatments: AUTO1 and AUTO4, both of which are types of CAR T cell therapies. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. Another treatment involved in the study is rituximab, known by the brand name MabThera, which is also given as an infusion. Rituximab is a medication that targets specific proteins on the surface of certain cells and is used in various conditions, including some types of cancer.

During the course of the study, participants will be monitored for any serious side effects related to the CAR T cell therapy, the development of new cancers, and other specific health events of interest. The study will also track overall survival rates and the duration of any supportive care needed. Additionally, researchers will look for any remaining genetic material from the therapy in the blood and check for any potential causes of new cancers. This follow-up will continue for up to 15 years after the initial CAR T cell therapy infusion.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient has previously received AUTO CAR T cell therapy and has provided informed consent for the long-term follow-up study.
Step 2
Treatment administration
The study involves monitoring patients who have previously been treated with genetically modified T cells. No new treatment is administered during this follow-up study.
Step 3
Monitoring and follow-up
Patients are monitored for any serious adverse events related to the previous AUTO CAR T cell therapy. This includes checking for new malignancies and other adverse events of special interest.
Regular follow-up visits are scheduled to assess overall survival, duration of response, and progression-free survival. These visits continue for up to 15 years after the first infusion of AUTO CAR T cell therapy.
Step 4
Blood tests
Blood tests are conducted to detect the presence of vector copy numbers in the peripheral blood. This monitoring is performed for up to 15 years from the first infusion.
Tests are also conducted to confirm the absence of detectable replication-competent retrovirus (RCR) or replication-competent lentivirus (RCL).
Step 5
Analysis in case of new malignancy
If a new malignancy is detected, an insertion site analysis is performed to determine if insertional mutagenesis is a potential cause or contributor.
Step 6
Study completion
The study is estimated to conclude on November 21, 2039. The long-term follow-up aims to ensure the safety of patients who have received AUTO CAR T cell therapy.

Who can join the trial?

6 criteria

Patients must have received an AUTO CAR T cell therapy on a previous treatment study. CAR T cell therapy is a type of treatment where a patient's own immune cells are changed in a lab to better fight cancer.
Patients must have provided informed consent for the long-term follow-up study before participating. Informed consent means that the patient understands the study and agrees to take part.
Patients must be able to comply with the study requirements. This means they should be able to follow the rules and procedures of the study.
Both male and female patients are eligible to participate.
The study includes patients from different age groups, including children, teenagers, and adults.
The study may include individuals who are considered part of a vulnerable population, meaning they might need extra protection or care.

Who cannot join the trial?

1 criterion

Patients who have a potential malignancy after receiving treatment with Autolus CAR T cell therapy cannot participate. A potential malignancy means there might be a risk of developing cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Y Politecnico La Fe
Verified
Valencia, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Autologous T Cells Genetically Modified with Viral Vectors These are a type of immune cell therapy where a patient's own T cells are collected and then modified in a laboratory using viral vectors. The viral vectors are used to introduce new genetic material into the T cells, which can help them better recognize and attack cancer cells or other diseased cells in the body. This therapy is being studied for its long-term safety in patients who have previously received this treatment.

What is already known about the treatment

Autolus CAR T Cell Therapy – This therapy is administered through an intravenous infusion, where genetically modified T cells are introduced into the patient's bloodstream. Currently, it is under clinical investigation for its long-term safety in patients who have previously received this treatment. The main therapeutic indication is for potential malignancies, particularly in patients who have undergone this specific CAR T cell therapy. At the molecular level, the therapy works by modifying T cells to better recognize and attack cancer cells. It falls under the pharmacological classification of gene therapy and immunotherapy.

Investigated diseases

Potential Malignancy – This condition refers to the possibility of developing cancerous growths in patients who have undergone specific treatments, such as Autolus CAR T cell therapy. It involves the transformation of normal cells into abnormal ones that may grow uncontrollably. The progression of potential malignancy can vary, with some cases remaining benign while others may develop into malignant tumors. Monitoring is essential to detect any changes in cell behavior that could indicate malignancy. The condition requires careful observation over time to assess any developments.