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Autologous Enriched T Cells Retrovirally Transduced To Express Two Chimeric Antigen Receptors Targeting Cd19 And Cd22

This article discusses clinical trials using AUTO1, an innovative CAR T-cell therapy targeting CD19 and CD22 in patients with relapsed or refractory B-cell leukemia and lymphoma. AUTO1 is being studied in both pediatric and adult populations, offering hope for patients who have not responded to conventional treatments. The trials aim to evaluate the safety, efficacy, and long-term effects of this groundbreaking therapy.

Table of Contents

What is AUTO1?

AUTO1 is an innovative cancer treatment known as CAR T-cell therapy. It is specifically designed to target and fight certain types of blood cancers. The full name of this therapy is “Autologous Enriched T Cells Retrovirally Transduced to Express Two Chimeric Antigen Receptors Targeting CD19 and CD22”[1]. While this name is quite technical, let’s break it down to understand what it means:

  • Autologous: This means the therapy uses your own cells.
  • T Cells: These are a type of white blood cell that helps your immune system fight diseases.
  • Retrovirally Transduced: This refers to the method used to modify the T cells.
  • Chimeric Antigen Receptors (CARs): These are special proteins added to the T cells to help them recognize and attack cancer cells.
  • CD19 and CD22: These are specific targets on cancer cells that the modified T cells are designed to recognize.

How does AUTO1 work?

AUTO1 works by enhancing your body’s natural defense system to fight cancer. Here’s a simplified explanation of the process:

  1. First, some of your T cells are collected from your blood.
  2. These T cells are then genetically modified in a laboratory to produce special receptors on their surface called chimeric antigen receptors (CARs).
  3. The CARs are designed to recognize and attach to specific proteins (CD19 and CD22) found on the surface of certain cancer cells.
  4. The modified T cells are grown in large numbers in the lab.
  5. Finally, these CAR T-cells are infused back into your body, where they can now recognize, attack, and potentially kill the cancer cells[2].

What conditions does AUTO1 treat?

AUTO1 is being developed to treat several types of blood cancers, specifically:

  • B-cell Acute Lymphoblastic Leukemia (B-ALL): This is a type of cancer that affects the blood and bone marrow. It’s characterized by the rapid growth of abnormal white blood cells called lymphoblasts[1].
  • Aggressive Mature B-cell Non-Hodgkin Lymphoma (B-NHL): This is a group of blood cancers that develop from lymphocytes (a type of white blood cell)[1].

It’s important to note that AUTO1 is primarily being studied for use in patients whose cancer has either come back after treatment (relapsed) or has not responded well to other treatments (refractory)[3].

Clinical Trials and Research

AUTO1 is currently being studied in several clinical trials to evaluate its safety and effectiveness. These trials include:

  • A study for pediatric patients (children and adolescents under 18) with relapsed or refractory B-ALL and B-NHL[1].
  • A study for adult patients (18 years and older) with relapsed or refractory B-ALL[3].

These trials are designed to assess how well AUTO1 works, how safe it is, and how feasible it is to manufacture and administer the treatment[3].

Potential Benefits

While research is still ongoing, AUTO1 shows promise in several areas:

  • Targeted therapy: By specifically targeting CD19 and CD22 proteins on cancer cells, AUTO1 may be more effective and potentially have fewer side effects than some traditional cancer treatments.
  • Personalized treatment: Since AUTO1 uses your own T cells, it’s a highly personalized form of treatment.
  • Potential for long-lasting effects: CAR T-cell therapies like AUTO1 have shown potential for long-lasting remission in some patients with certain types of blood cancers[2].

Safety and Side Effects

As with any medical treatment, AUTO1 may cause side effects. The clinical trials are carefully monitoring for:

  • Adverse events (AEs) and serious adverse events (SAEs)
  • Severe hypogammaglobulinemia (a condition where the immune system doesn’t produce enough antibodies)
  • B-cell aplasia (a decrease in the number of B cells, which are another type of white blood cell)[3]

It’s important to note that the full range of potential side effects is still being studied in the ongoing clinical trials.

Long-Term Follow-Up

Because AUTO1 involves genetic modification of cells, patients who receive this treatment will be monitored for up to 15 years after treatment. This long-term follow-up is designed to:

  • Monitor for any long-term side effects
  • Track the persistence of the CAR T-cells in the body
  • Check for any potential development of new cancers
  • Assess overall survival and long-term effectiveness of the treatment[2]

Conclusion

AUTO1 represents an exciting advancement in the field of cancer treatment. As a form of CAR T-cell therapy, it offers a personalized approach to fighting certain types of blood cancers. While the research is still ongoing, early studies show promise for patients with relapsed or refractory B-ALL and B-NHL. As with any medical treatment, it’s important to discuss the potential benefits and risks with your healthcare provider to determine if participating in a clinical trial for AUTO1 might be appropriate for your specific situation.

Aspect Details
Therapy Name AUTO1
Type CAR T-cell therapy targeting CD19 and CD22
Target Conditions Relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and aggressive mature B-cell Non-Hodgkin Lymphoma (B-NHL)
Patient Population Both pediatric (< 18 years) and adult patients
Primary Objectives Evaluate safety, tolerability, and preliminary efficacy
Secondary Objectives Assess expansion and persistence of modified T cells, duration of B cell aplasia, overall survival
Key Inclusion Criteria CD19-positive relapsed/refractory disease, adequate organ function
Key Exclusion Criteria Certain CNS pathologies, active infections, prior CD19-targeted therapies (except blinatumomab)
Follow-up Duration Up to 15 years post-infusion
Monitoring Adverse events, efficacy markers, CAR T-cell persistence, B cell aplasia, potential long-term effects

FAQ

  • What is AUTO1? AUTO1 is a type of CAR T-cell therapy that uses a patient's own T cells, which are genetically modified to express two chimeric antigen receptors targeting CD19 and CD22 on cancer cells. This therapy is being studied for the treatment of relapsed or refractory B-cell leukemia and lymphoma.
  • Who is eligible for AUTO1 clinical trials? Eligibility varies by trial, but generally includes patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or aggressive mature B-cell non-Hodgkin lymphoma (B-NHL). Some trials focus on pediatric patients under 18 years old, while others include adult patients aged 18 and older.
  • What are the main objectives of the AUTO1 clinical trials? The main objectives of these trials are to evaluate the safety and tolerability of AUTO1, assess its preliminary clinical efficacy, and study the expansion and persistence of the modified T cells in patients' bodies.
  • What are the potential side effects of AUTO1 therapy? While specific side effects are being studied in the trials, common side effects of CAR T-cell therapies may include cytokine release syndrome, neurological toxicities, and B cell aplasia. The trials are closely monitoring for adverse events and serious adverse events related to AUTO1 treatment.
  • How long will patients be followed after receiving AUTO1? Patients receiving AUTO1 may be followed for up to 15 years after the first infusion to monitor long-term safety, efficacy, and potential late effects of the therapy. This includes monitoring for new malignancies and other designated adverse events of special interest.

Ongoing Clinical Trials on Autologous Enriched T Cells Retrovirally Transduced To Express Two Chimeric Antigen Receptors Targeting Cd19 And Cd22

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Effects of AUTO1, Cyclophosphamide, and Fludarabine Phosphate in Children with Relapsed or Refractory B-cell Leukemia and Non-Hodgkin Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A Study of Obecabtagene Autoleucel for Patients with Severe Lupus and Active Kidney Inflammation Not Responding to Standard Treatment

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

  • Study on the Safety and Effectiveness of AUTO1 for Adults with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia Using a Drug Combination

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • CAR T-cell therapy: A type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood, then the gene for a special receptor called a chimeric antigen receptor (CAR) is added to them in the lab. The CAR T cells are then given back to the patient to help fight their cancer.
  • B-cell Acute Lymphoblastic Leukemia (B-ALL): A type of cancer in which the bone marrow makes too many immature lymphocytes (a type of white blood cell). B-ALL specifically affects B-lymphocytes, which are important for fighting infections.
  • Non-Hodgkin Lymphoma (NHL): A type of cancer that starts in lymphocytes (white blood cells that are part of the immune system). NHL can develop in many parts of the body, including the lymph nodes, spleen, bone marrow, blood, or other organs.
  • Relapsed/Refractory (r/r): Relapsed means the disease has returned after a period of improvement. Refractory means the disease does not respond to treatment or stops responding after initial improvement.
  • Chimeric Antigen Receptor (CAR): A special protein created in the laboratory that is designed to bind to specific targets on cancer cells. When added to T cells, it helps them find and attack cancer cells more effectively.
  • CD19 and CD22: Proteins found on the surface of B cells, including some types of leukemia and lymphoma cells. These proteins are targets for CAR T-cell therapies like AUTO1.
  • Minimal Residual Disease (MRD): Small numbers of cancer cells that remain in the body during or after treatment. These cells are often too few to be detected by standard tests but can be found using more sensitive techniques.
  • Cytokine Release Syndrome (CRS): A condition that may occur after treatment with some types of immunotherapy, including CAR T-cell therapy. Symptoms may include fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing.
  • B cell aplasia: A condition where the body does not produce B cells, which are a type of white blood cell important for fighting infections. This can be a side effect of CAR T-cell therapies targeting B cells.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-auto1-cyclophosphamide-and-fludarabine-phosphate-in-children-with-relapsed-or-refractory-b-cell-leukemia-and-non-hodgkin-lymphoma/
  2. http://clinicaltrials.eu/trial/long-term-safety-study-of-auto4-and-rituximab-in-patients-with-potential-malignancy-treated-with-autologous-car-t-cell-therapy/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-auto1-for-adults-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-using-a-drug-combination/