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CLIC-1901 CAR T-cell therapy is an innovative treatment being studied for patients with relapsed or refractory CD19-positive blood cancers, including acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. This clinical trial aims to evaluate the safety, feasibility, and effectiveness of CLIC-1901 CAR T-cells in patients who have not responded to or have relapsed after standard treatments.

Table of Contents

What is CLIC-1901 CAR T-Cell Therapy?

CLIC-1901 CAR T-cell therapy is an innovative treatment being developed for patients with certain types of blood cancers that have not responded well to other treatments or have come back after previous therapies[1]. This therapy belongs to a category of treatments called advanced therapy medicinal products (ATMPs), specifically a type of cell therapy that uses genetically modified cells to fight cancer.

How Does CLIC-1901 CAR T-Cell Therapy Work?

CLIC-1901 CAR T-cell therapy works by using the patient’s own immune cells, specifically T-cells, which are a type of white blood cell. These cells are collected from the patient and then modified in a laboratory using a lentiviral vector, which is a tool that helps introduce new genetic material into the cells[1]. This genetic modification equips the T-cells with a special receptor called a Chimeric Antigen Receptor (CAR) that targets a protein called CD19, which is found on the surface of certain cancer cells.

Once modified, these CAR T-cells are grown in large numbers and then infused back into the patient. The modified cells are designed to recognize and attack cancer cells that have the CD19 protein, potentially providing a powerful and targeted treatment for certain blood cancers.

What Conditions Does CLIC-1901 CAR T-Cell Therapy Target?

CLIC-1901 CAR T-cell therapy is being developed to treat several types of blood cancers that express the CD19 protein. These include[1]:

  • Acute Lymphoblastic Leukemia (ALL): A fast-growing cancer of lymphocyte-producing cells in the bone marrow
  • B-cell Non-Hodgkin Lymphoma (NHL): A group of blood cancers that develop from lymphocytes (a type of white blood cell)
  • Diffuse Large B-cell Lymphoma (DLBCL): The most common type of non-Hodgkin lymphoma
  • Burkitt Lymphoma: A rare but aggressive form of NHL
  • Primary Mediastinal Large B-cell Lymphoma: A subtype of DLBCL that typically occurs in young adults
  • Mantle Cell Lymphoma: A rare type of B-cell NHL
  • Transformed Follicular Lymphoma: When a slow-growing lymphoma changes into a more aggressive form
  • Richter-transformed Chronic Lymphocytic Leukemia (CLL): When CLL transforms into an aggressive lymphoma

The DAN-CART 1901 Clinical Trial

A clinical trial called DAN-CART 1901 is currently underway to test the safety and effectiveness of CLIC-1901 CAR T-cell therapy[1]. This is a Phase II-III trial, which means it’s in a later stage of testing where researchers are looking closely at how well the treatment works and any side effects it might cause.

The main goals of this trial are:

  1. To test the safety and feasibility of using CLIC-1901 CAR T-cells in patients with relapsed or refractory CD19-expressing blood cancers
  2. To evaluate how effective the treatment is in fighting these cancers
  3. To analyze factors that might contribute to the treatment not working in some cases
  4. To study biological and immunological markers during the treatment

Who is Eligible for the CLIC-1901 CAR T-Cell Therapy Trial?

The trial is open to patients aged 1-70 years who have certain types of relapsed or refractory blood cancers that express the CD19 protein[1]. Some key eligibility criteria include:

  • Having a blood cancer that has come back (relapsed) or not responded to previous treatments (refractory)
  • Having adequate organ function
  • Having a life expectancy of at least 12 weeks
  • Not having active central nervous system involvement by the cancer
  • Not having had prior gene therapy treatment
  • Not having certain active infections or other medical conditions that might interfere with the treatment

It’s important to note that there are additional specific criteria that doctors use to determine if a patient is eligible for the trial.

Safety and Efficacy Measures

The researchers will be closely monitoring several aspects of the treatment to assess its safety and effectiveness[1]. These include:

  • Response rates to the treatment
  • Overall survival and progression-free survival of patients
  • How long it takes for blood cell counts to recover after treatment
  • The need for additional treatments after CAR T-cell therapy

Potential Side Effects

As with any new treatment, there are potential side effects that the researchers will be carefully monitoring[1]. Some of the main side effects they’re watching for include:

  • Cytokine Release Syndrome (CRS): A condition where the immune system becomes highly activated, potentially causing fever, low blood pressure, and other symptoms
  • Neurotoxicity: Side effects that affect the nervous system, which could include confusion, seizures, or other neurological symptoms
  • Prolonged cytopenia: A prolonged decrease in blood cell counts, which could increase the risk of infections or bleeding
  • Infections: Including episodes of neutropenic fever (fever with a low white blood cell count)

The trial includes plans for managing these potential side effects, including the use of medications like tocilizumab and glucocorticoids if needed.

Aspect Details
Study Name DK-CLIC-1901 CAR T-cells for treatment of patients with relapsed/refractory CD19 positive hematological malignancies (DAN-CART 1901)
Trial Category Phase II-III clinical trial
Target Conditions Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma
Age Range 1-70 years
Main Objective Test safety and feasibility of CLIC-1901 CAR T-cell treatment
Primary Endpoints CRS, Neurotoxicity, Treatment with tocilizumab/glucocorticoids, Prolonged cytopenia, Neutropenic fever, ICU admission, Death from any cause
Secondary Endpoints Response rates, Overall survival, Progression-free survival, Non-relapse mortality, Treatment with allogeneic HSCT
Drug Information CLIC-1901 CAR T-cells, administered via IV infusion, maximum daily dose 200 million organisms
Follow-up Period Minimum 12 months after CAR T-cell infusion

FAQ

  • What is CLIC-1901 CAR T-cell therapy? CLIC-1901 CAR T-cell therapy is a type of gene therapy that uses a patient's own immune cells (T-cells) modified to target and fight cancer cells expressing the CD19 protein on their surface.
  • Who is eligible for this clinical trial? Patients aged 1-70 years with relapsed or refractory CD19-positive blood cancers, such as B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma, who have not responded to standard treatments or have relapsed after previous therapies.
  • What are the main objectives of the trial? The main objectives are to test the safety and feasibility of CLIC-1901 CAR T-cell treatment in patients with relapsed or refractory CD19-expressing blood cancers, as well as to evaluate its effectiveness and analyze factors that may contribute to treatment failure.
  • What are the potential side effects of CLIC-1901 CAR T-cell therapy? Potential side effects include cytokine release syndrome (CRS), neurotoxicity, prolonged low blood cell counts, and infections. The trial will closely monitor these side effects and use treatments like tocilizumab and corticosteroids if needed.
  • How long will patients be followed after receiving CLIC-1901 CAR T-cell therapy? Patients will be followed for at least 12 months after receiving the CAR T-cell infusion to monitor for side effects, treatment response, and long-term outcomes such as overall survival and progression-free survival.

Ongoing Clinical Trials on Clic-1901 Cart

  • Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • CAR T-cell therapy: A type of treatment that uses a patient's own T-cells (a type of immune cell) that have been genetically modified to target and kill cancer cells.
  • CD19: A protein found on the surface of certain blood cancer cells, which is targeted by the CLIC-1901 CAR T-cells.
  • Relapsed: When cancer returns after a period of improvement or remission following treatment.
  • Refractory: When cancer does not respond to or stops responding to a particular treatment.
  • Cytokine Release Syndrome (CRS): A potential side effect of CAR T-cell therapy where the immune system becomes overactive, causing symptoms like fever, low blood pressure, and difficulty breathing.
  • Neurotoxicity: Harmful effects on the nervous system, which can be a side effect of CAR T-cell therapy.
  • Tocilizumab: A medication used to treat cytokine release syndrome, a potential side effect of CAR T-cell therapy.
  • Leukapheresis: A procedure to collect white blood cells, including T-cells, from a patient's blood for use in CAR T-cell therapy.
  • Allogeneic hematopoietic stem cell transplantation (HSCT): A procedure where a patient receives blood-forming stem cells from a donor to replace their own stem cells that have been damaged by disease or treatment.
  • Complete remission (CR): When there is no detectable cancer in the body after treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-clic-1901-car-t-cells-and-tocilizumab-for-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-and-b-cell-non-hodgkin-lymphoma/