Exploring new drug impact and safety on relapsed B-cell leukemia

Recruting new patients

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    What is this study about?

    This is a scientific study for people who have a type of blood cancer known as B-cell Acute Lymphoblastic Leukemia (B-ALL) which has come back or is not responding to treatments anymore. The main goal of this important research is to test a new engineered cell treatment named UCART22. This trial is going to try and figure out the safest and most effective dose to give people. The researchers will also pay close attention to how patients react to the treatment and any side effects that occur. This might include anything from minor issues to serious health events that are directly related to the trial.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Nantes , France

      Paris , France

      Paris , France

      Pierre-Benite , France

      Rennes , France

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients go through a specific set of steps, which involve a dose escalation process and the administration of a biological intervention. Here are the steps outlined in the clinical trial document:

      1. Patients will participate in a dose escalation stage where several tested doses of UCART22 will be administered until the Maximum Tolerated Dose (MTD) is identified.
      2. Once the MTD is established, the trial will proceed to establish the Recommended Phase 2 Dose (RP2D).
      3. During the dose expansion phase, UCART22 will be administered at the RP2D.
      4. UCART22 is an allogeneic engineered T-cell therapy expressing an anti-CD22 Chimeric Antigen Receptor. This will be given to patients following a lymphodepleting regimen.
      5. Also involved in the intervention is CLLS52, which is a monoclonal antibody recognizing CD52 antigen.

      Unfortunately, due to a technical issue, I couldn’t provide specific quotes from the document. The steps mentioned are based on the information available in the clinical trial document about the interventions and procedures patients will undergo. If you need more detailed information or have further questions, please let me know!


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have B-cell Acute Lymphoblastic Leukemia (B-ALL).


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The conditions you must meet to join the study are as follows:

      1. B-ALL blast cells expressing CD22: Your B-cell Acute Lymphoblastic Leukemia (B-ALL) cells must show expression of the CD22 antigen, which is a molecule found on the surface of the cancer cells.
      2. Diagnosed with R/R B-ALL: You should be diagnosed with relapsed/refractory B-cell Acute Lymphoblastic Leukemia, which means the leukemia has not responded to standard treatments or has come back after treatment.
      3. Prior therapy: You must have received at least one standard chemotherapy regimen, which is the initial treatment protocol to combat the cancer, and at least one salvage regimen, which is the treatment given after the cancer does not respond to the initial standard therapy.

      These inclusions criteria ensure that participants have a specific type of leukemia that the clinical trial is targeting and have already undergone certain treatments that are typical for the disease.

      What Reasons Could Exclude Me from the Study?

      Conditions when you cannot take part in the study:

      1. Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment:
        • Cellular therapy: A treatment in which live cells are injected into a patient; examples include stem cell transplants and some types of immunotherapy.
        • Investigational cellular or gene therapy: Treatments that are still being researched and have not been approved by regulatory agencies. They may involve modifying cells or genes to treat a disease.

      This is the exclusion criterion provided in the document. If there are additional criteria you want to know about, please let me know so I can further check the document.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The study involves two biological interventions:

      1. UCART22: This is a preparation of allogeneic engineered T-cells that express an anti-CD22 Chimeric Antigen Receptor. It is given after a lymphodepleting regimen.
      2. CLLS52 (Alemtuzumab): This intervention consists of a monoclonal antibody that recognizes a CD52 antigen.

      A brief description of each active substance is as follows:

      1. Anti-CD22 Chimeric Antigen Receptor (expressed by UCART22): This genetically engineered receptor is designed to redirect T-cells to target and eliminate cells expressing the CD22 antigen, which is found on the surface of certain leukemia cells.

      2. Alemtuzumab (Active substance in CLLS52): Alemtuzumab is a monoclonal antibody targeting CD52, a protein present on the surface of immune cells. By binding to CD52, alemtuzumab depletes these immune cells, which can be involved in the pathology of certain leukemias and autoimmune diseases.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the provided clinical trial information, there are two active substances being studied:

      1. UCART22
        • UCART22 is described as “allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor”. This suggests it is an investigational cellular therapy specifically developed for this trial, so it is likely not an already well-known substance in medicine and medical literature.
      2. CLLS52 (Alemtuzumab)
        • Alemtuzumab is a monoclonal antibody that recognizes the CD52 antigen. It is listed under “Other Names” for the CLLS52 intervention, indicating alemtuzumab is already an established medication, known to medicine and the medical literature.

      Study ID

      CT-EU-00084049

      Recruitment status

      Recruting new patients

      Start of the trial

      5 years ago

      Study phase

      Phase
      I

      Medicinal Product