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Carcik-Cd19 Cells

CARCIK-CD19 cells are being studied in a Phase II clinical trial for patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL). This innovative therapy aims to improve response rates and duration of response in both pediatric and adult patients. The trial focuses on a measurable residual disease-driven strategy, potentially offering new hope for those who have not responded well to previous treatments.

Table of Contents

What is CARCIK-CD19?

CARCIK-CD19 is an innovative cell therapy being studied for the treatment of a specific type of blood cancer[1]. The full name of this treatment is “PTG-CARCIK-CD19,” and it’s classified as a suspension for injection[1]. This means that the treatment is given to patients through an infusion, which is a method of delivering medication directly into the bloodstream.

Target Condition: B-cell Precursor Acute Lymphoblastic Leukemia

CARCIK-CD19 is being studied to treat a condition called B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL)[1]. This is a type of blood cancer that affects a specific kind of white blood cell called B-cells. In this disease, immature B-cells (precursors) grow out of control in the bone marrow, which is where blood cells are made. The term “acute” means the disease progresses quickly, and “lymphoblastic” refers to the immature cells involved.

Specifically, CARCIK-CD19 is being tested for patients whose BCP-ALL has either come back after treatment (relapsed) or hasn’t responded well to previous treatments (refractory)[1]. These cases are often more challenging to treat, which is why new therapies like CARCIK-CD19 are being developed.

How CARCIK-CD19 Works

CARCIK-CD19 is a type of treatment called cell therapy[1]. Here’s a simple explanation of how it works:

  1. The therapy uses special cells that have been modified in a laboratory.
  2. These modified cells are designed to target and attack cancer cells that have a specific marker called CD19 on their surface.
  3. When infused into the patient’s body, these CARCIK-CD19 cells seek out and destroy the cancer cells that have the CD19 marker.

This targeted approach is designed to be more effective at fighting the cancer while potentially causing fewer side effects compared to traditional treatments like chemotherapy.

Clinical Trial Details

CARCIK-CD19 is currently being studied in a Phase II clinical trial[1]. Here are some key points about the trial:

  • The main goal is to confirm how well patients respond to CARCIK-CD19 and to see if it can improve how long the response lasts[1].
  • The trial is looking at the overall response rate 28 days after the first CARCIK-CD19 infusion[1].
  • It’s also studying how long the response lasts from day 70 onwards for patients who achieved and maintained remission after one or two CARCIK-CD19 administrations[1].
  • The trial is investigating the safety of giving a second dose of CARCIK-CD19 cells[1].

Eligibility Criteria

Not everyone with BCP-ALL can participate in this trial. Here are some of the main criteria for eligibility:

  • Age: The trial is open to children (ages 1-17) and adults (ages 18-75)[1].
  • Disease status: Patients must have relapsed or refractory BCP-ALL, with at least 5% leukemia cells in their bone marrow, or if less than 5%, at least 1% detectable by a sensitive test called PCR[1].
  • CD19 expression: The patient’s cancer cells must show evidence of having the CD19 marker[1].
  • General health: Patients must have a life expectancy of more than 60 days and be in relatively good overall health[1].

There are also several conditions that would prevent a person from participating in the trial, such as certain infections, pregnancy, or specific organ problems[1].

Treatment Administration

CARCIK-CD19 is given as an infusion, which means it’s delivered directly into the bloodstream[1]. The trial is studying the effects of one or two infusions of CARCIK-CD19 cells. The maximum total dose amount is 15 units (the specific unit of measurement isn’t specified in the provided information)[1].

Potential Benefits

While the effectiveness of CARCIK-CD19 is still being studied, the potential benefits being investigated include:

  • Improved response rates in patients with difficult-to-treat BCP-ALL[1].
  • Longer-lasting remissions (periods when cancer signs and symptoms are reduced or gone)[1].
  • Potentially improved overall survival (how long patients live after starting treatment)[1].

Safety Considerations

As with any new treatment, safety is a crucial aspect being studied in the CARCIK-CD19 trial. The researchers are carefully monitoring:

  • The safety of giving a second dose of CARCIK-CD19 cells[1].
  • The safety of using CARCIK-CD19 cells from different sources (autologous, which means from the patient’s own cells, and from cord blood)[1].
  • Any side effects or complications that may occur during or after treatment.

It’s important to note that as this is an experimental treatment, not all potential risks and side effects may be known at this time.

Aspect Details
Study Type Phase II clinical trial
Therapy CARCIK-CD19 cells
Target Condition Relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL)
Age Range 1-75 years (children and adults)
Primary Objectives Confirm high overall response rate at day 28; Improve duration of response
Secondary Objectives Overall survival; Safety of second administration
Key Inclusion Criteria CD19 tumor expression; ≥5% lymphoblasts or ≥1% molecular disease
Key Exclusion Criteria Active CNS involvement; Recent cell therapy; Severe organ dysfunction
Administration Infusion (one or two doses)

FAQ

  • What is CARCIK-CD19 cell therapy? CARCIK-CD19 cell therapy is a type of immunotherapy that uses modified immune cells to target and fight cancer cells expressing CD19, a protein found on the surface of B-cells in leukemia.
  • Who is eligible for this clinical trial? The trial is open to children (1-17 years) and adults (18-75 years) with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL) who meet specific health criteria and have evidence of CD19 tumor expression.
  • How is the CARCIK-CD19 therapy administered? CARCIK-CD19 cells are administered through infusion. The trial involves one or two infusions, depending on the patient's response to the first treatment.
  • What are the main goals of this clinical trial? The main objectives are to confirm a high overall response rate 28 days after the first CARCIK-CD19 infusion and to improve the duration of response in treated patients.
  • Are there any specific exclusion criteria for the trial? Yes, some exclusion criteria include active central nervous system involvement by malignancy, pregnancy or breastfeeding, HIV/HBV/HCV infection, and certain levels of graft-versus-host disease in previously transplanted patients.

Ongoing Clinical Trials on Carcik-Cd19 Cells

  • Study of CARCIK-CD19 Cells for Patients with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Acute Lymphoblastic Leukemia (ALL): A type of cancer that affects the blood and bone marrow, causing rapid growth of immature white blood cells called lymphoblasts.
  • B-cell precursor ALL (BCP-ALL): A specific subtype of ALL that originates from immature B-cells, which are a type of white blood cell.
  • CD19: A protein found on the surface of B-cells, often used as a target for immunotherapies in B-cell cancers.
  • Measurable Residual Disease (MRD): The small number of cancer cells that remain in the body during or after treatment, which can be detected using sensitive laboratory tests.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Duration of Response (DOR): The length of time that a tumor continues to respond to treatment without growing or spreading.
  • Graft-versus-Host Disease (GVHD): A potential complication following a stem cell or bone marrow transplant, where the donated cells attack the recipient's body.
  • Karnofsky/Lansky Score: A scale used to measure a patient's general well-being and ability to perform daily activities.
  • Refractory Cancer: Cancer that does not respond to treatment.
  • Relapsed Cancer: Cancer that returns after a period of improvement.

References

  1. http://clinicaltrials.eu/trial/study-of-carcik-cd19-cells-for-patients-with-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukemia/