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Ddcart‐Cd19

A new clinical trial is investigating the use of DDCART-CD19, a donor-derived CD19-targeted CAR T-cell therapy, for children and young adults with relapsed acute leukemia. This Phase 2 study aims to evaluate the safety and effectiveness of DDCART-CD19 in patients who have experienced a recurrence of their disease after stem cell transplantation or previous CAR T-cell therapy. The trial focuses on patients aged 6 months to 39 years old and seeks to provide hope for those who have limited treatment options.

Table of Contents

What is DDCART-CD19?

DDCART-CD19 is a new type of medicine being studied to treat certain kinds of leukemia that have come back or haven’t gone away after previous treatments. It’s what doctors call a donor-derived CD19-targeted CAR T cell therapy. This means it’s made from special immune cells (T cells) that come from a donor, not the patient themselves.[1]

Who Can Benefit from DDCART-CD19?

This treatment is being developed for children and young adults (up to 39 years old) who have a type of cancer called relapsed acute leukemia. Specifically, it’s for patients whose leukemia cells have a marker called CD19 on their surface. These patients must have already tried other treatments, including a stem cell transplant from a donor or a different kind of CAR T cell therapy, but their cancer has either come back or never fully went away.[1]

How Does DDCART-CD19 Work?

DDCART-CD19 is a type of cell therapy. Here’s how it works:

  1. T cells (a type of immune cell) are taken from the person who originally donated stem cells to the patient.
  2. These cells are changed in a laboratory using a lentivirus. This virus adds a new gene to the T cells, giving them the ability to recognize and attack cancer cells with CD19 on their surface.
  3. The modified T cells (now called CAR T cells) are grown in large numbers.
  4. The CAR T cells are then given back to the patient through an IV (intravenous) infusion.
  5. Once in the patient’s body, these special T cells can find and destroy leukemia cells.[1]

Current Clinical Trial: ELPIDA-ALLOCART-01

DDCART-CD19 is currently being studied in a clinical trial called ELPIDA-ALLOCART-01. This is a Phase 2 study, which means researchers are testing how well the treatment works and how safe it is. The official name of the study is “A Phase 2 Study of the Efficacy and Safety of a Dose of Donor-Derived CD19-targeted CAR T cells for children and young adults (up to 39 years old) with recurrent or persistent CD19 (+) Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)”.[1]

Who is Eligible for the Trial?

The study is looking for patients who meet certain criteria, including:

  • Age between 6 months and 39 years
  • Have relapsed or persistent CD19-positive acute leukemia after a stem cell transplant or previous CAR T cell therapy
  • Have a certain amount of leukemia cells in their bone marrow or other parts of the body
  • Are healthy enough to participate (measured by a performance status score)
  • Have their original stem cell donor available[1]

Some reasons why a patient might not be able to participate include having a severe active infection, ongoing graft-versus-host disease, or if their leukemia cells don’t have enough CD19 on the surface.

What are the Objectives of the Study?

The main goals of this study are:

  • To see how well DDCART-CD19 works in treating the leukemia
  • To check if it’s safe for patients
  • To look at how long the CAR T cells stay in the patient’s body
  • To see if it causes B-cell aplasia (a temporary loss of B cells, which can be a sign that the treatment is working)
  • To see if it causes any graft-versus-host disease (a potential complication of donor cells)[1]

How is DDCART-CD19 Administered?

DDCART-CD19 is given as a solution for infusion. This means it’s a liquid that’s put directly into the patient’s bloodstream through an IV. The exact dose can vary, but the maximum daily dose mentioned in the trial information is 5,000,000 units, with a maximum total dose of 10,000,000 units over a period of up to 2 days.[1]

Potential Benefits of DDCART-CD19

While the study is still ongoing and we don’t know all the results yet, the researchers hope that DDCART-CD19 might offer several benefits:

  • It might help patients achieve remission (when signs of cancer disappear) within 30 days of treatment.
  • It could potentially keep patients in remission for 6 months, 1 year, or even 2 years after treatment.
  • The CAR T cells might stay in the patient’s body for a long time, continuing to fight against the leukemia.
  • It might cause B-cell aplasia, which, while it sounds bad, can actually be a sign that the treatment is working against the leukemia.[1]

It’s important to remember that DDCART-CD19 is still being studied, and more research is needed to fully understand its effects and benefits. If you think this treatment might be right for you or someone you know, it’s crucial to discuss it with a healthcare provider who can provide personalized medical advice.

Aspect Details
Study Type Phase 2 clinical trial
Treatment DDCART-CD19 (donor-derived CD19-targeted CAR T-cells)
Target Condition Relapsed or persistent CD19+ acute leukemia
Age Range 6 months to 39 years old
Primary Objectives Evaluate efficacy and safety, assess GVHD incidence, determine CAR T-cell generation
Key Eligibility Criteria Relapse after allo-HSCT or CAR T-cell therapy, ≥5 X 10-4 CD19+ blast cells in bone marrow, no active severe GVHD
Primary Endpoint Proportion of patients achieving complete remission within 30 days
Administration Intravenous infusion

FAQ

  • What is DDCART-CD19? DDCART-CD19 is a type of cell therapy where immune cells (T-cells) from a donor are modified to target CD19, a protein found on certain leukemia cells. These modified cells are then given to the patient to help fight the cancer.
  • Who is eligible for this clinical trial? The trial is open to individuals between 6 months and 39 years of age who have relapsed or persistent CD19-positive acute leukemia after a stem cell transplant or previous CAR T-cell therapy. Patients must meet specific criteria, including having a certain number of leukemia cells in their bone marrow and no signs of severe graft-versus-host disease.
  • How is DDCART-CD19 administered? DDCART-CD19 is given as a solution for infusion, which means it is administered directly into the bloodstream through an intravenous (IV) line.
  • What are the main goals of this clinical trial? The main objectives are to evaluate the effectiveness and safety of DDCART-CD19, assess the occurrence of graft-versus-host disease, and determine how well the modified T-cells are produced using a specific device called CliniMACS Prodigy.
  • How will the effectiveness of DDCART-CD19 be measured? The primary measure of effectiveness will be the proportion of patients who achieve complete remission within 30 days after receiving DDCART-CD19. The study will also look at how long the remission lasts, tracking patients at 6 months, 1 year, and 2 years after treatment.

Ongoing Clinical Trials on Ddcart‐Cd19

  • Study of DDCART-CD19 cells with cyclophosphamide and fludarabine for children and young adults (up to 39 years) with recurrent acute leukemia after stem cell transplant

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

Glossary

  • Acute Leukemia: A fast-growing cancer of the blood and bone marrow that affects the production of normal blood cells.
  • Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT): A procedure where a patient receives blood-forming stem cells from a donor to replace their diseased bone marrow.
  • CAR T-cell therapy: A type of treatment where a patient's T-cells (a type of immune cell) are modified in a laboratory to recognize and attack cancer cells.
  • CD19: A protein found on the surface of certain types of blood cells, including some leukemia cells, which can be targeted by specially designed treatments.
  • Complete Remission (CR): A state where there are no detectable signs of cancer in the body after treatment.
  • Graft-versus-Host Disease (GVHD): A potential complication of stem cell transplants where the donor cells attack the recipient's body. It can be acute (aGVHD) or chronic (cGVHD).
  • B-cell aplasia: A condition where the body doesn't produce B-cells, a type of white blood cell important for the immune system.
  • Extramedullary relapse: The return of cancer in areas outside the bone marrow.
  • Lansky/Karnofsky performance status: Scales used to assess a patient's overall physical ability and quality of life.
  • CliniMACS Prodigy device: A machine used to process and modify cells for cell therapy treatments.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-ddcar-cd19-cyclophosphamide-and-fludarabine-phosphate-for-children-and-young-adults-with-relapsed-acute-leukemia/